PlainRecalls
FDA Drug Moderate Class II Completed

Rite Aid Pharmacy Maximum Strength Ranitidine Tablets, USP 150 mg-acid reducer Distributed By: Rite Aid 30 Hunter Lane Camp Hill, PA 17011 a) 50 tablets NDC 11822-6052-1; b) 65 tablets NDC 11822-6052-2; c) 95 tablets NDC 11822-4727-3; d) 24 tablets NDC 11822-6051-8

Reported: November 20, 2019 Initiated: September 24, 2019 #D-0319-2020

Product Description

Rite Aid Pharmacy Maximum Strength Ranitidine Tablets, USP 150 mg-acid reducer Distributed By: Rite Aid 30 Hunter Lane Camp Hill, PA 17011 a) 50 tablets NDC 11822-6052-1; b) 65 tablets NDC 11822-6052-2; c) 95 tablets NDC 11822-4727-3; d) 24 tablets NDC 11822-6051-8

Reason for Recall

GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA).

Details

Recalling Firm
Apotex Inc.
Units Affected
215,387 bottles
Distribution
Nationwide
Location
North York, N/A

Frequently Asked Questions

What product was recalled?
Rite Aid Pharmacy Maximum Strength Ranitidine Tablets, USP 150 mg-acid reducer Distributed By: Rite Aid 30 Hunter Lane Camp Hill, PA 17011 a) 50 tablets NDC 11822-6052-1; b) 65 tablets NDC 11822-6052-2; c) 95 tablets NDC 11822-4727-3; d) 24 tablets NDC 11822-6051-8. Recalled by Apotex Inc.. Units affected: 215,387 bottles.
Why was this product recalled?
GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA).
Which agency issued this recall?
This recall was issued by the FDA Drug on November 20, 2019. Severity: Moderate. Recall number: D-0319-2020.