D-0164-2020 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- November 6, 2019
- Initiation Date
- October 17, 2019
- Termination Date
- October 21, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7293 bottles
Product Description
AVKARE Ranitidine Hydrochloride Capsules 150 mg 500 Capsules Rx Only NDC 42291-735-50 UPC 342291735507 Manufactured for: AvKARE, Inc. Pulaski, TN 38478
Reason for Recall
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Distribution Pattern
CO, MO
Code Information
Lot 17708 Exp.11/30/2019 Lot 18459 Exp.03/31/2020 Lot 19033 Exp.07/31/2020 Lot 19032 Exp.07/31/2020 Lot 19031 Exp.06/30/2020 Lot 20204 Exp.09/30/2020 Lot 20205 Exp.09/30/2020 Lot 20663 Exp.10/31/2020 Lot 20664 Exp.11/30/2020 Lot 20665 Exp.11/30/2020 Lot 20666 Exp.11/30/2020 Lot 21039 Exp.12/31/2020 Lot 21920 Exp.04/30/2021