Recalls / Class II
Class IID-0525-2020
Product
AVKARE Ranitidine Tablets, USP 300 mg Rx Only NDC Manufactured for: AvKARE, Inc. Pulaski, TN 38478 a) 250 tablets NDC 42291-725-25; b) 30 tablets NDC 42291-725-30
- Affected lot / code info
- Lots: a) 21307 Exp. 02/29/2020, 21309 Exp. 02/29/2020, 21528 Exp. 02/29/2020, 21527 Exp. 02/29/2020, 22247 Exp. 06/30/2020, 23214 Exp. 09/30/2020, 23243 Exp. 09/30/2020, 23244 Exp. 11/30/2020, 24198 Exp. 01/31/2021, 24199 Exp. 01/31/2021, 24289 Exp. 01/31/2021; b) 22291 Exp. 06/30/2020, 23215 Exp. 09/30/2020, 23776 Exp. 01/31/2021
Why it was recalled
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Recalling firm
- Firm
- AVKARE Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 615 N 1st St, Pulaski, Tennessee 38478-2403
Distribution
- Quantity
- 104,797 bottles
- Distribution pattern
- Nationwide.
Timeline
- Recall initiated
- 2019-11-14
- FDA classified
- 2019-11-26
- Posted by FDA
- 2019-12-04
- Terminated
- 2021-10-27
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0525-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.