McNeil Consumer Healthcare Announces Voluntary Recall of Certain Over-The-Counter (OTC) Products in the Americas,…
In appointment with the U.S. Food and Drug Administration (FDA), McNeil Consumer Healthcare, Division of McNEIL-PPC, Inc., is voluntarily abandoning assertive lots of OTC articles in the Americas, the United Arab Emirates (UAE), and Fiji (FULL RECALLED PRODUCT LIST BELOW). The aggregation is initiating this anamnesis afterward an analysis of chump letters of an abnormal moldy, musty, or mildew-like odor that, in a baby amount of cases, was associated with acting and non-serious gastrointestinal events. These cover nausea, abdomen pain, vomiting, or diarrhea. This basic action is autonomous and has been taken in appointment with the FDA.
Based on this investigation, McNeil Consumer Healthcare has bent that the appear accidental that appears to smell is acquired by the attendance of trace amounts of a actinic alleged 2,4,6-tribromoanisole (TBA). This can aftereffect from the breakdown of a actinic that is sometimes activated to copse that is acclimated to body copse pallets that carriage and abundance artefact packaging materials. The bloom accoutrement of this actinic accept not been able-bodied advised but no austere contest accept been accurate in the medical literature. A baby amount of the artefact lots accepting recalled were associated with the complaints of an abnormal moldy, musty, or mildew-like odor, and some of these lots were begin to accommodate trace amounts of TBA. In December 2009, McNeil Consumer Healthcare aswell recalled all lots of TYLENOL® Arthritis Pain 100 calculation with EZ-OPEN CAP accompanying to this issue. McNeil Consumer Healthcare has now activated broader belief to analyze and abolish all artefact lots that it believes may accept the abeyant to be affected, even if they accept not been the accountable of chump complaints.
In accession to the artefact recall, McNeil Consumer Healthcare is continuing their analysis into this affair and is demography added accomplishments that cover abeyance addition of articles produced application abstracts alien on these copse pallets and acute suppliers who address abstracts to our plants to abandon the use of these pallets. We will abide to carefully adviser and appraise the bearings and argue with the FDA.
Consumers who purchased artefact from the lots included in this anamnesis should stop application the artefact and acquaintance McNeil Consumer Healthcare for instructions on a acquittance or replacement. For these instructions or advice apropos how to acknowledgment or actuate of the product, consumers should log on to the internet at www.mcneilproductrecall.com or alarm 1-888-222-6036 (Monday-Friday 8 a.m. to 10 p.m. Eastern Time, and Saturday-Sunday 9 a.m. to 5 p.m. Eastern Time). Consumers who accept medical apropos or questions should acquaintance their healthcare provider. Any adverse reactions may aswell be appear to the FDA’s MedWatch Program by fax at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.
The afflicted artefact lot numbers for the recalled articles can be begin on the ancillary of the canteen label.
McNeil Consumer Healthcare Division of McNeil-PPC, Inc. markets a ample ambit of acclaimed and trusted over-the-counter (OTC) products.
FULL RECALLED PRODUCT LIST:
|
Product Form |
Product Name |
Lot Number |
UPC Code |
||
|
CHILDREN’S |
CAPLET |
Junior Strength Motrin IB Caplet 24 ct |
AJM322 |
300450498243 |
|
|
MOTRIN |
APM348 |
300450498243 |
|||
|
CHEWABLE |
Junior Strength Motrin Grape Chewable |
ADM006 |
300450909244 |
||
|
Grape 24 ct |
ADM052 |
300450909244 |
|||
|
AFM016 |
300450909244 |
||||
|
AFM350 |
300450909244 |
||||
|
AHM420 |
300450909244 |
||||
|
AJM346 |
300450909244 |
||||
|
ALM344 |
300450909244 |
||||
|
ALM399 |
300450909244 |
||||
|
AMM379 |
300450909244 |
||||
|
APM303 |
300450909244 |
||||
|
APM418 |
300450909244 |
||||
|
APM429 |
300450909244 |
||||
|
SLM084 |
300450909244 |
||||
|
Junior Strength Motrin Orange Chewable |
ADM013 |
300450494245 |
|||
|
Tablet 24 ct |
AFM024 |
300450494245 |
|||
|
AHM402 |
300450494245 |
||||
|
AJM345 |
300450494245 |
||||
|
ALM326 |
300450494245 |
||||
|
ALM456 |
300450494245 |
||||
|
AMM381 |
300450494245 |
||||
|
APM306 |
300450494245 |
||||
|
APM421 |
300450494245 |
||||
|
CHILDREN’S |
MELTAWAY |
Children’s Tylenol Bubble Gum Meltaway |
AHA069 |
300450519306 |
|
|
TYLENOL |
Tablet 30 ct |
SPA022 |
300450519306 |
||
|
Children’s Tylenol Grape Meltaways Tablet |
AHA023 |
300450518309 |
|||
|
30 ct |
AHA057 |
300450518309 |
|||
|
BENADRYL |
TABLET |
Benadryl Allergy Tablet 148 ct |
AAA422 |
300450226143 |
|
|
ABA392 |
300450226143 |
||||
|
AJA094 |
300450226143 |
||||
|
ALA034 |
300450226143 |
||||
|
EXTRA |
CAPLET |
Extra Strength Tylenol Caplet 24 ct |
AAA408 |
300450449054 |
|
|
STRENGTH |
ABA169 |
300450449054 |
|||
|
TYLENOL |
ABA568 |
300450449054 |
|||
|
ADA192 |
300450449054 |
||||
|
AHA048 |
300450449054 |
||||
|
AJA145 |
300450449054 |
||||
|
Product Form |
Product Name |
Lot Number |
UPC Code |
||
|
EXTRA |
CAPLET |
Extra Strength Tylenol Caplet 24+12 ct |
ABA565 |
300450444318 |
|
|
STRENGTH |
AHA040 |
300450444318 |
|||
|
TYLENOL |
AJA028 |
300450444318 |
|||
|
Extra Strength Tylenol Caplet 50 ct |
24862 |
350580451502 |
|||
|
24881 |
350580451502 |
||||
|
24901 |
350580451502 |
||||
|
24970 |
350580451502 |
||||
|
25994 |
350580451502 |
||||
|
26054 |
350580451502 |
||||
|
26213 |
350580451502 |
||||
|
26305 |
350580451502 |
||||
|
26356 |
350580451502 |
||||
|
26377 |
350580451502 |
||||
|
26515 |
350580451502 |
||||
|
26541 |
350580451502 |
||||
|
AEA206 |
300450449078 |
||||
|
AFA176 |
300450449078 |
||||
|
AFA325 |
300450449078 |
||||
|
AHA072 |
300450449078 |
||||
|
AJA021 |
300450449078 |
||||
|
Extra Strength Tylenol Caplet 50+25 ct |
ACA599 |
300450444752 |
|||
|
ACA755 |
300450444752 |
||||
|
Extra Strength Tylenol Caplet 100 ct |
AMA008 |
300450449092 |
|||
|
SSA013 |
300450449092 |
||||
|
SSA150 |
300450449092 |
||||
|
Extra Strength Tylenol Caplet 100+25 ct |
SDA203 |
300450449009 |
|||
|
SHA035 |
300450449009 |
||||
|
Extra Strength Tylenol Caplet 150 ct |
AAA419 |
300450449238 |
|||
|
SEA199 |
300450449238 |
||||
|
SPA007 |
300450449238 |
||||
|
Extra Strength Tylenol Caplet 150+50 ct |
SFA071 |
300450449467 |
|||
|
Extra Strength Tylenol Caplet 225 ct |
SSA011 |
300450444271 |
|||
|
Extra Strength Tylenol Caplet 325 ct |
09BMC018 |
300450444325 |
|||
|
09CMC048 |
300450444325 |
||||
|
09FMC082 |
300450444325 |
||||
|
09FMC084 |
300450444325 |
||||
|
AAA405 |
300450444325 |
||||
|
ADA014 |
300450444325 |
||||
|
ADA087 |
300450444325 |
||||
|
Product Form |
Product Name |
Lot Number |
UPC Code |
||
|
EXTRA |
CAPLET |
Extra Strength Tylenol Caplet 325 ct |
ADA270 |
300450444325 |
|
|
STRENGTH |
ADA271 |
300450444325 |
|||
|
TYLENOL |
ADA417 |
300450444325 |
|||
|
AEA348 |
300450444325 |
||||
|
AFA102 |
300450444325 |
||||
|
AJA045 |
300450444325 |
||||
|
ALA028 |
300450444325 |
||||
|
SFA179 |
300450444325 |
||||
|
SFA237 |
300450444325 |
||||
|
SFA295 |
300450444325 |
||||
|
SHA002 |
300450444325 |
||||
|
SJA025 |
300450444325 |
||||
|
SJA189 |
300450444325 |
||||
|
SJA232 |
300450444325 |
||||
|
SLA004 |
300450444325 |
||||
|
SLA160 |
300450444325 |
||||
|
SLA296 |
300450444325 |
||||
|
SMA173 |
300450444325 |
||||
|
SMA174 |
300450444325 |
||||
|
SPA005 |
300450444325 |
||||
|
SPA038 |
300450444325 |
||||
|
SPA058 |
300450444325 |
||||
|
SPA386 |
300450444325 |
||||
|
SSA055 |
300450444325 |
||||
|
COOL |
Extra Strength Tylenol Cool Caplet 50 ct |
ABA029 |
300450444509 |
||
|
CAPLET |
ACA563 |
300450444509 |
|||
|
ADA190 |
300450444509 |
||||
|
AHA081 |
300450444509 |
||||
|
AJA095 |
300450444509 |
||||
|
AJA175 |
300450444509 |
||||
|
Extra Strength Tylenol Cool Caplet 100 ct |
ALA249 |
300450444103 |
|||
|
EZ TABLET |
Extra Strength Tylenol EZ Tab 24 ct |
ABA154 |
300450422248 |
||
|
ADA193 |
300450422248 |
||||
|
AFA243 |
300450422248 |
||||
|
AHA039 |
300450422248 |
||||
|
Extra Strength Tylenol EZ Tab 50 ct |
ADA013 |
300450422507 |
|||
|
AEA259 |
300450422507 |
||||
|
AHA091 |
300450422507 |
||||
|
Product Form |
Product Name |
Lot Number |
UPC Code |
||
|
EXTRA |
EZ TABLET |
Extra Strength Tylenol EZ Tab 50 ct |
AJA010 |
300450422507 |
|
|
STRENGTH |
AJA123 |
300450422507 |
|||
|
TYLENOL |
Extra Strength Tylenol EZ Tab 50+25 ct |
ACA562 |
300450422750 |
||
|
ACA743 |
300450422750 |
||||
|
ALA173 |
300450422750 |
||||
|
RAPID |
Extra Strength Tylenol Rapid Release |
ABA020 |
300450488244 |
||
|
RELEASE |
Gelcap 24 ct |
ABA371 |
300450488244 |
||
|
GELCAP |
ADA280 |
300450488244 |
|||
|
AHA082 |
300450488244 |
||||
|
Extra Strength Tylenol Rapid Release |
ACA451 |
300450488503 |
|||
|
Gelcap 50 ct |
AEA061 |
300450488503 |
|||
|
AEA244 |
300450488503 |
||||
|
AFA103 |
300450488503 |
||||
|
AFA240 |
300450488503 |
||||
|
AHA046 |
300450488503 |
||||
|
AHA080 |
300450488503 |
||||
|
AJA040 |
300450488503 |
||||
|
AJA041 |
300450488503 |
||||
|
Extra Strength Tylenol Rapid Release |
ALA253 |
300450488176 |
|||
|
Gelcap 100+20 ct |
AMA015 |
300450488176 |
|||
|
Extra Strength Tylenol Rapid Release Gelcap 150 ct |
ASA015 |
300450488152 |
|||
|
Extra Strength Tylenol Rapid Release |
09AMC008 |
300450488213 |
|||
|
Gelcap 290 ct |
AAA049 |
300450488213 |
|||
|
AAA360 |
300450488213 |
||||
|
ADA022 |
300450488213 |
||||
|
ADA178 |
300450488213 |
||||
|
ADA272 |
300450488213 |
||||
|
ADA482 |
300450488213 |
||||
|
AEA194 |
300450488213 |
||||
|
AFA010 |
300450488213 |
||||
|
AFA292 |
300450488213 |
||||
|
AHA035 |
300450488213 |
||||
|
AHA089 |
300450488213 |
||||
|
AJA167 |
300450488213 |
||||
|
ALA095 |
300450488213 |
||||
|
ALA096 |
300450488213 |
||||
|
SEA191 |
300450488299 |
||||
|
SEA192 |
300450488299 |
||||
|
Product Form |
Product Name |
Lot Number |
UPC Code |
||
|
EXTRA |
RAPID |
Extra Strength Tylenol Rapid Release |
SFA025 |
300450488299 |
|
|
STRENGTH |
RELEASE |
Gelcap 290 ct |
SFA026 |
300450488299 |
|
|
TYLENOL |
GELCAP |
SFA136 |
300450488299 |
||
|
SFA296 |
300450488213 |
||||
|
SHA039 |
300450488213 |
||||
|
SHA234 |
300450488213 |
||||
|
SLA052 |
300450488299 |
||||
|
SLA198 |
300450488299 |
||||
|
SLA270 |
300450488213 |
||||
|
SMA236 |
300450488213 |
||||
|
SPA037 |
300450488213 |
||||
|
SPA357 |
300450488213 |
||||
|
SSA019 |
300450488213 |
||||
|
SSA030 |
300450488213 |
||||
|
SSA054 |
300450488213 |
||||
|
TABLET |
Extra Strength Tylenol Tablet 60 ct |
AEA243 |
300450499684 |
||
|
MOTRIN IB |
CAPLET |
Motrin IB Caplet 24 ct |
AAA435 |
300450481030 |
|
|
ABA369 |
300450481030 |
||||
|
ADA174 |
300450481030 |
||||
|
AHA026 |
300450481030 |
||||
|
AJA006 |
300450481030 |
||||
|
Motrin IB Caplet 24+6 ct |
ADA246 |
300450481641 |
|||
|
Motrin IB Caplet 50 ct |
ABA153 |
300450481023 |
|||
|
ABA541 |
300450481023 |
||||
|
ADA173 |
300450481023 |
||||
|
AHA025 |
300450481023 |
||||
|
Motrin IB Caplet 100 ct |
ABA019 |
300450481016 |
|||
|
ACA469 |
300450481016 |
||||
|
ADA245 |
300450481016 |
||||
|
AEA260 |
300450481016 |
||||
|
AFA015 |
300450481016 |
||||
|
AJA049 |
300450481016 |
||||
|
AJA186 |
300450481016 |
||||
|
Motrin IB Caplet 100+25 ct |
ADA287 |
300450481955 |
|||
|
AFA016 |
300450481955 |
||||
|
Motrin IB Caplet 100+50 ct |
ABA538 |
300450481757 |
|||
|
AJA023 |
300450481757 |
||||
|
AJA120 |
300450481757 |
||||
|
Motrin IB Caplet 225 ct |
24526 |
300450481627 |
|||
|
Product Form |
Product Name |
Lot Number |
UPC Code |
||
|
MOTRIN IB |
CAPLET |
Motrin IB Caplet 225 ct |
24544 |
300450481627 |
|
|
24591 |
300450481627 |
||||
|
24604 |
300450481627 |
||||
|
24634 |
300450481627 |
||||
|
24687 |
300450481627 |
||||
|
24762 |
300450481627 |
||||
|
24794 |
300450481627 |
||||
|
24795 |
300450481627 |
||||
|
24818 |
300450481627 |
||||
|
24864 |
300450481627 |
||||
|
24905 |
300450481627 |
||||
|
24915 |
300450481627 |
||||
|
24935 |
300450481627 |
||||
|
24939 |
300450481627 |
||||
|
24977 |
300450481627 |
||||
|
25013 |
300450481627 |
||||
|
25044 |
300450481627 |
||||
|
25980 |
300450481627 |
||||
|
25996 |
300450481627 |
||||
|
26051 |
300450481627 |
||||
|
26085 |
300450481627 |
||||
|
26134 |
300450481627 |
||||
|
26192 |
300450481627 |
||||
|
26241 |
300450481627 |
||||
|
26335 |
300450481627 |
||||
|
26423 |
300450481627 |
||||
|
26455 |
300450481627 |
||||
|
26508 |
300450481627 |
||||
|
26533 |
300450481627 |
||||
|
Motrin IB Caplet 300 ct |
ACA442 |
300450481375 |
|||
|
ACA759 |
300450481375 |
||||
|
ADA018 |
300450481375 |
||||
|
ADA419 |
300450481375 |
||||
|
AFA098 |
300450481375 |
||||
|
AFA112 |
300450481375 |
||||
|
AHA034 |
300450481375 |
||||
|
AHA068 |
300450481375 |
||||
|
ALA254 |
300450481375 |
||||
|
ALA359 |
300450481375 |
||||
|
Product Form |
Product Name |
Lot Number |
UPC Code |
||
|
MOTRIN IB |
CAPLET |
Motrin IB Caplet 300 ct |
AMA177 |
300450481375 |
|
|
AMA350 |
300450481375 |
||||
|
APA217 |
300450481375 |
||||
|
SEA208 |
300450481375 |
||||
|
SFA184 |
300450481375 |
||||
|
SFA259 |
300450481375 |
||||
|
SHA107 |
300450481375 |
||||
|
SJA131 |
300450481375 |
||||
|
SLA049 |
300450481375 |
||||
|
SLA162 |
300450481375 |
||||
|
SMA013 |
300450481375 |
||||
|
SMA082 |
300450481375 |
||||
|
SSA157 |
300450481375 |
||||
|
TABLET |
Motrin IB Tablet 24 ct |
ABA003 |
300450463029 |
||
|
ADA258 |
300450463029 |
||||
|
AFA309 |
300450463029 |
||||
|
AJA055 |
300450463029 |
||||
|
Motrin IB Tablet 50 ct |
ABA004 |
300450463036 |
|||
|
ABA152 |
300450463036 |
||||
|
AFA228 |
300450463036 |
||||
|
AHA024 |
300450463036 |
||||
|
AJA007 |
300450463036 |
||||
|
AJA243 |
300450463036 |
||||
|
Motrin IB Tablet 100 ct |
AEA078 |
300450463043 |
|||
|
AEA261 |
300450463043 |
||||
|
AFA241 |
300450463043 |
||||
|
Motrin IB Tablet 100+25 ct |
AFA017 |
300450463296 |
|||
|
AJA168 |
300450463296 |
||||
|
Motrin IB Tablet 100+50 ct |
ALA109 |
300450463753 |
|||
|
REGULAR |
CAPLET |
Regular Strength Tylenol Caplet 50 ct |
24777 |
350580501504 |
|
|
STRENGTH |
24900 |
350580501504 |
|||
|
TYLENOL |
24971 |
350580501504 |
|||
|
25971 |
350580501504 |
||||
|
26019 |
350580501504 |
||||
|
26133 |
350580501504 |
||||
|
26271 |
350580501504 |
||||
|
26422 |
350580501504 |
||||
|
26482 |
350580501504 |
||||
|
26521 |
350580501504 |
||||
|
Product Form |
Product Name |
Lot Number |
UPC Code |
||
|
REGULAR |
TABLET |
Regular Strength Tylenol Tablet 100 ct |
ABA148 |
300450496607 |
|
|
STRENGTH |
ABA266 |
300450496607 |
|||
|
TYLENOL |
ABA373 |
300450496607 |
|||
|
ACA432 |
300450496607 |
||||
|
AFA101 |
300450496607 |
||||
|
AHA070 |
300450496607 |
||||
|
AJA009 |
300450496607 |
||||
|
ALA099 |
300450496607 |
||||
|
AMA018 |
300450496607 |
||||
|
ROLAIDS |
CHEWABLE |
Extra Strength Rolaids Freshmint Tablet |
AAA011 |
312547650212 |
|
|
100 ct |
AAA083 |
312547650212 |
|||
|
AAA399 |
312547650212 |
||||
|
ABA397 |
312547650212 |
||||
|
ACA439 |
312547650212 |
||||
|
ADA086 |
312547650212 |
||||
|
ADA180 |
312547650212 |
||||
|
AEA197 |
312547650212 |
||||
|
AEA250 |
312547650212 |
||||
|
AFA053 |
312547650212 |
||||
|
AFA224 |
312547650212 |
||||
|
AFA293 |
312547650212 |
||||
|
AJA043 |
312547650212 |
||||
|
AJA114 |
312547650212 |
||||
|
ALA105 |
312547650212 |
||||
|
ALA159 |
312547650212 |
||||
|
ALA273 |
312547650212 |
||||
|
AMA178 |
312547650212 |
||||
|
APA054 |
312547650212 |
||||
|
SJA113 |
312547650212 |
||||
|
SJA114 |
312547650212 |
||||
|
SJA115 |
312547650212 |
||||
|
SJA116 |
312547650212 |
||||
|
SJA259 |
312547650212 |
||||
|
SLA149 |
312547650212 |
||||
|
SMA032 |
312547650212 |
||||
|
SMA222 |
312547650212 |
||||
|
SMA248 |
312547650212 |
||||
|
SPA024 |
312547650212 |
||||
|
SPA128 |
312547650212 |
||||
|
Product Form |
Product Name |
Lot Number |
UPC Code |
||
|
ROLAIDS |
CHEWABLE |
Extra Strength Rolaids Fresh Mint Tablet |
SPA161 |
312547650212 |
|
|
100 ct |
SSA351 |
312547650212 |
|||
|
Extra Strength Rolaids Fruit Tablet 100 ct |
AAA086 |
312547650243 |
|||
|
ABA262 |
312547650243 |
||||
|
ACA256 |
312547650243 |
||||
|
ADA028 |
312547650243 |
||||
|
ADA082 |
312547650243 |
||||
|
AEA195 |
312547650243 |
||||
|
AFA234 |
312547650243 |
||||
|
AJA017 |
312547650243 |
||||
|
AJA018 |
312547650243 |
||||
|
AJA180 |
312547650243 |
||||
|
ALA026 |
312547650243 |
||||
|
AMA051 |
312547650243 |
||||
|
AMA208 |
312547650243 |
||||
|
APA152 |
312547650243 |
||||
|
SMA031 |
312547650243 |
||||
|
SMA099 |
312547650243 |
||||
|
SMA100 |
312547650243 |
||||
|
SMA101 |
312547650243 |
||||
|
SSA331 |
312547650243 |
||||
|
SSA332 |
312547650243 |
||||
|
Extra Strength Rolaids Tropical Punch |
AAA359 |
312547654234 |
|||
|
Tablet 100 ct |
SHA016 |
312547654234 |
|||
|
SHA017 |
312547654234 |
||||
|
SHA018 |
312547654234 |
||||
|
SJA204 |
312547654234 |
||||
|
SLA151 |
312547654234 |
||||
|
SSA175 |
312547654234 |
||||
|
Multi Symptom Rolaids Berry Tablet 100 ct |
ABA009 |
312547654579 |
|||
|
ABA010 |
312547654579 |
||||
|
ABA011 |
312547654579 |
||||
|
ABA417 |
312547654579 |
||||
|
ABA620 |
312547654579 |
||||
|
ACA438 |
312547654579 |
||||
|
ALA256 |
312547654579 |
||||
|
APA042 |
312547654579 |
||||
|
ASA012 |
312547654579 |
||||
|
Original Rolaids Cherry Tablet 150 ct |
ACA013 |
312547652421 |
|||
|
Product Form |
Product Name |
Lot Number |
UPC Code |
||
|
ROLAIDS |
CHEWABLE |
Original Rolaids Cherry Tablet 150 ct |
AEA057 |
312547652421 |
|
|
AFA317 |
312547652421 |
||||
|
AJA016 |
312547652421 |
||||
|
AMA165 |
312547652421 |
||||
|
APA009 |
312547652421 |
||||
|
SLA087 |
312547652421 |
||||
|
SPA036 |
312547652421 |
||||
|
SSA334 |
312547652421 |
||||
|
SSA438 |
312547652421 |
||||
|
Original Rolaids Peppermint Tablet 150 ct |
AAA009 |
312547651158 |
|||
|
AAA202 |
312547651158 |
||||
|
AAA232 |
312547651158 |
||||
|
ABA141 |
312547651158 |
||||
|
ABA268 |
312547651158 |
||||
|
ABA416 |
312547651158 |
||||
|
ABA554 |
312547651158 |
||||
|
ACA567 |
312547651158 |
||||
|
ADA268 |
312547651158 |
||||