D-0525-2020 Class II Terminated
FDA drug recall D-0525-2020 was initiated by AVKARE Inc. on November 14, 2019 and is designated Class II. Reason for recall: CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API The recall status is terminated (terminated October 27, 2021). Affected quantity: 104,797 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- December 4, 2019
- Initiation Date
- November 14, 2019
- Termination Date
- October 27, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 104,797 bottles
Product Description
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
Reason for Recall
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Distribution Pattern
Nationwide.
Code Information
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