AVKARE Ranitidine Hydrochloride Capsules 300 mg 500 Capsules Rx Only NDC 42291-736-50 UPC 342291736504 Manufactured for: AvKARE, Inc. Pulaski, TN 38478
Reported: November 6, 2019 Initiated: October 17, 2019 #D-0165-2020
Product Description
AVKARE Ranitidine Hydrochloride Capsules 300 mg 500 Capsules Rx Only NDC 42291-736-50 UPC 342291736504 Manufactured for: AvKARE, Inc. Pulaski, TN 38478
Reason for Recall
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Details
- Recalling Firm
- AVKARE Inc.
- Units Affected
- 1351 bottles
- Distribution
- CO, MO
- Location
- Pulaski, TN
Frequently Asked Questions
What product was recalled? ▼
AVKARE Ranitidine Hydrochloride Capsules 300 mg 500 Capsules Rx Only NDC 42291-736-50 UPC 342291736504 Manufactured for: AvKARE, Inc. Pulaski, TN 38478. Recalled by AVKARE Inc.. Units affected: 1351 bottles.
Why was this product recalled? ▼
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on November 6, 2019. Severity: Moderate. Recall number: D-0165-2020.
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