Perrigo Holland Inc: Nicotine Polacrilex Lozenge, 2 mg Mint Mini. 27 Ct Tubes, Over the Counter. Perrigo, 502 Eastern Ave, Plant #6, Allegan, MI 49010. Labeled: A) CareOne, 81 and 108 Ct Cartons, Dist

Is my product affected?

Nicotine Polacrilex Lozenge, 2 mg Mint Mini. 27 Ct Tubes, Over the Counter. Perrigo, 502 Eastern Ave, Plant #6, Allegan, MI 49010. Labeled: A) CareOne, 81 and 108 Ct Cartons, Distributed by: Foodhold U.S.A., LLD, Landover, MD 20785, NDC: 41520-734-02, 41520-734-03, B) CVS Pharmacy, 81 Ct Cartons, Di

• Brand CAREONE NICOTINE
• Brand NICOTINE
• Brand EQUATE NICOTINE
• Brand NICOTINE MINI

Check against the official notice below — it lists the full affected range.

What happened

Perrigo Holland Inc is recalling nicotine polacrilex lozenges sold under the CareOne brand in 27-count tubes and 20-count packages. The mint-flavored 2 mg lozenges are being recalled because some units failed quality tests, including dissolving too slowly during a 30-minute dissolution test and containing broken lozenges. The recall affects approximately 366,936 tubes distributed in Ohio, Rhode Island, Oregon, Pennsylvania, Minnesota, Illinois, and Arkansas.

The affected products include specific lot numbers expiring between September 2014 and March 2015. Consumers who have purchased these lozenges should check the lot number on their package against the list provided in the recall notice. The recall record does not specify what consumers should do with recalled products.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Failed Dissolution Specifications and Failed Tablet Specifications: High 30 minute dissolution test and presence of broken lozenges.

Details from the source

Reason for recall: Failed Dissolution Specifications and Failed Tablet Specifications: High 30 minute dissolution test and presence of broken lozenges. Distribution: U.S. Distribution: OH, RI, OR, PA, MN, IL, AR. Quantity: 366,936 Tubes Lot/code info: Cartons of 27 ct Tubes: Lot #: 2MV1074, Expiry: 09/14; Lot #: 2MV1124, Expiry: 09/14; Lot #: 2MV1142, Expiry: 09/14; Lot #: 2MV1143, Expiry: 09/14; Lot #: 3AV0528, Expiry: 09/14; Lot #: 3FV0575, Expiry: 09/14; Lot #: 3FV0535, Expiry: 03/15; Lot #: 3FV0537, Expiry: 03/15; Lot #: 3FV0576, Expiry: 03/15; Lot #: 3FV0579, Expiry: 03/15; Lot #: 3FV0615, Expiry: 03/15; Lot #: 3FV0739, Expiry: 03/15; Lot #: 3FV0742, Expiry: 03/15, Lot #: 3GV0713, Expiry: 03/15; Lot #: 3GV0715, Expiry: 03/15, Lot #: 3FV0421, Expiry: 03/15, Lot #: 3FV0422, Expiry: 03/15; Lot #: 3FV0423, Expiry: 03/15; Lot #: 3FV0740, Expiry: 03/15. 20 Ct Stretchcard: Lot #: 3FV0520, Expiry: 03/15.

Source

Official record: FDA (Drug enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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