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D-0319-2020 Class II

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

FDA drug recall D-0319-2020 was initiated by Apotex Inc. on Sep 24, 2019 and is designated Class II. Reason for recall: GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA). Affected quantity: 215,387 bottles.

Recall details

Product Type: Drugs
Report Date: Nov 20, 2019
Initiation Date: Sep 24, 2019
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.

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-0319-2020
openFDA file date: Nov 10, 2026
Loaded by RegDataLab: Nov 11, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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