# FDA recall D-1558-2014

> **Perrigo Holland Inc** · Class III · drug recall initiated 2014-08-19.

## Product

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,  Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, NDC: 59779-734-02, C) equate, 27, 108, and 135 Ct Cartons, Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72716, NDC: 49035-734-01, 49035-734-03, 49035-734-04, D) Kroger, 81 Ct Cartons, Distributed by: The Kroger Co., Cincinnati, Ohio 45202, NDC: 30142-734-02, E) Rite Aid, 81 and 108 Ct Cartons, Distributed by: Rite Aid, 30 Hunter Lane, Camp Hill, PA 17011, NDC: 11822-0734-3, 11822-0734-2, F) TopCare, 81 Ct Cartons, Distributed by Topco Associates LLC., Elk Grove Villiage, IL 60007, NDC: 36800-734-60 G) Walgreens, 81 and 135 Ct Cartons, Distributed by: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015, NDC: 03

## 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.

## Key facts

- **Recall number:** D-1558-2014
- **Recalling firm:** Perrigo Holland Inc
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2014-08-19
- **Report date:** 2014-09-03
- **Termination date:** 2015-01-13

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Holland, MI, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1558-2014

## Citation

> AI Analytics. FDA recall D-1558-2014. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/D-1558-2014. Source: US FDA. Licensed CC0.

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