Home / Recalls / Denton Pharma, Inc. / D-0795-2020

D-0795-2020 Class II Terminated

Recalled by Denton Pharma, Inc. — North Blenheim, NY

Recall Details

Product Type
Drugs
Report Date
January 29, 2020
Initiation Date
December 20, 2019
Termination Date
October 5, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
467 bottles

Product Description

Ranitidine Tablets, USP 300 mg a). 15-count bottles (NDC 70934-287-15), b). 90-count bottles (NDC 70934-287-90), Rx Only, Repackaged by: Northwind Pharmaceuticals North Brenheim, NY 12131

Reason for Recall

CGMP Deviations: Presence of NDMA impurity detected in product.

Distribution Pattern

Nationwide

Code Information

a). N106851901, Exp. 11/30/2021 N106851902, Exp. 10/31/2021 b). C106851901, Exp. 11/30/2021 C106851902 Exp. 10/31/2021 C106851903 Exp. 02/28/2022 C106851904 Exp. 11/30/2021 C106851905 Exp. 05/31/2022

Other recalls by Denton Pharma, Inc.

  • D-0057-2021 Class II — Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, a) 30 count (NDC 7 (October 8, 2020)
  • D-0056-2021 Class II — Metformin Hydrochloride Extended-Release Tablets USP 750 mg, 30 Tablets bottle, (October 8, 2020)
  • D-0794-2020 Class II — Ranitidine Tablets, USP 150 mg , a). 4 count bottle (NDC 70934-017-04), b). 20-c (December 20, 2019)