Recalls / Class II
Class IID-0165-2020
Product
AVKARE Ranitidine Hydrochloride Capsules 300 mg 500 Capsules Rx Only NDC 42291-736-50 UPC 342291736504 Manufactured for: AvKARE, Inc. Pulaski, TN 38478
- Affected 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
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
- 1351 bottles
- Distribution pattern
- CO, MO
Timeline
- Recall initiated
- 2019-10-17
- FDA classified
- 2019-10-28
- Posted by FDA
- 2019-11-06
- Terminated
- 2020-10-21
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0165-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.