D-0319-2020 Class II

Recalled by Apotex Inc. — North York, N/A

Recall Details

Product Type
Drugs
Report Date
November 20, 2019
Initiation Date
September 24, 2019
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
215,387 bottles

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).

Distribution Pattern

Nationwide

Code Information

All lots remaining within expiry.