Class II
Terminated
AVKARE Ranitidine Hydrochloride Capsules 300 mg 500 Capsules Rx Only NDC 42291-736-50 UPC 342291736504 Manufactured for: AvKARE, Inc. Pulaski, TN 38478
- Company
- Avkare Inc.
- Recall Initiated
- October 17, 2019
- Posted
- November 6, 2019
- Recall Number
- D-0165-2020
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 1351 bottles
- Firm Location
- Pulaski, TN, United States
Reason for Recall
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Distribution
CO, MO
Lot / Code Info
Lot 17709 Exp.01/31/2020 Lot 18460 Exp.02/29/2020 Lot 19853 Exp.09/30/2020 Lot 22362 Exp.11/30/2020 Lot 22579 Exp.11/30/2020
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