Home / Recalls / Denton Pharma, Inc. / D-0056-2021

D-0056-2021 Class II Ongoing

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

Recall Details

Product Type
Drugs
Report Date
November 11, 2020
Initiation Date
October 8, 2020
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
N/A

Product Description

Metformin Hydrochloride Extended-Release Tablets USP 750 mg, 30 Tablets bottle, Rx Only, Time-Cap Labs, Inc., Repackaged By: Northwind Pharmaceuticals North Blenheim NY 12131 NDC 70934-334-30

Reason for Recall

CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)

Distribution Pattern

Indiana - Nationwide.

Code Information

N107411901, N107411903, N107411904, N107411905, N107411906, exp 11/30/2020; N107411907, N107412001, exp 4/30/2021; N107412002, N107412004, exp 11/30/2021; N107412003, exp 7/31/2021

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-0795-2020 Class II — Ranitidine Tablets, USP 300 mg a). 15-count bottles (NDC 70934-287-15), b). 90-c (December 20, 2019)
  • D-0794-2020 Class II — Ranitidine Tablets, USP 150 mg , a). 4 count bottle (NDC 70934-017-04), b). 20-c (December 20, 2019)