Perrigo Recalls CareOne Nicotine Lozenges for Dissolution Failures
Perrigo Holland Inc is recalling CareOne Nicotine Polacrilex Lozenges because they failed dissolution tests and contained broken lozenges.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The FDA classified this as a Class III recall, which indicates the product is not likely to cause adverse health consequences. The issue involves failed dissolution specifications and physical defects (broken lozenges) without reported injuries.
Plain-English summary
Perrigo Holland Inc is recalling 366,936 tubes of CareOne Nicotine Polacrilex Lozenges, 2 mg Mint Mini. The affected products are available in 27-count tubes and 20-count stretchcards, distributed under various brand names including CareOne, CVS Pharmacy, equate, Kroger, Rite Aid, TopCare, Walgreens, and Target.
The recall was initiated because the lozenges failed to meet dissolution specifications, specifically showing high 30-minute dissolution results, and because broken lozenges were present in the product. The affected lots have expiration dates of 09/14 and 03/15.
The products were distributed in Ohio, Rhode Island, Oregon, Pennsylvania, Minnesota, Illinois, and Arkansas. Consumers should stop using the recalled lozenges and return them to the place of purchase for a refund or contact the manufacturer for further instructions.
The recalled product
- Product
- CAREONE NICOTINE (NICOTINE POLACRILEX)
- Brand
- CAREONE NICOTINE
- Manufacturer
- Perrigo Holland Inc
- Category
- Drug — OTC Nicotine Replacement
- Affected units
- 366,936
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Cartons of 27 ct Tubes: Lot #: 2MV1074
- Expiry: 09/14
- Lot #: 2MV1124
- Lot #: 2MV1142
- Lot #: 2MV1143
- Lot #: 3AV0528
- Lot #: 3FV0575
- Lot #: 3FV0535
- Expiry: 03/15
- Lot #: 3FV0537
- Lot #: 3FV0576
- Lot #: 3FV0579
- Lot #: 3FV0615
- Lot #: 3FV0739
- Lot #: 3FV0742
- Lot #: 3GV0713
- Lot #: 3GV0715
- Lot #: 3FV0421
- Lot #: 3FV0422
- Lot #: 3FV0423
UPCs (1)
- 0012345678905
Distribution
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