Home / Recalls / Nostrum Laboratories Inc / D-0068-2021

D-0068-2021 Class II Ongoing

Recalled by Nostrum Laboratories Inc — Kansas City, MO

Recall Details

Product Type
Drugs
Report Date
November 11, 2020
Initiation Date
October 23, 2020
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
20,872 bottles

Product Description

Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, 100 count bottles, Rx Only. Manufactured by: Nostrum Laboratories, Inc. Kansas City, MO 64120. NDC 29033-055-01

Reason for Recall

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

Distribution Pattern

Nationwide

Code Information

MET100201, MET100401 EXP 05/2022

Other recalls by Nostrum Laboratories Inc

  • D-0547-2025 Class II — Sucralfate Tablets, USP 1 gram, packaged in a) 100-count bottles NDC 29033-0003- (July 11, 2025)
  • D-0249-2021 Class II — Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg, 100 Tablets per b (January 25, 2021)
  • D-0227-2021 Class II — Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg, 100 tablets per b (January 4, 2021)
  • D-0067-2021 Class II — Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 count bottles, (October 23, 2020)
  • D-1059-2020 Class II — Theophylline (Anhydrous) Extended-Release Tablets, 400 mg, 100-count bottle, Rx (March 6, 2020)
  • D-0473-2018 Class III — Calcium Acetate Capsules, 667 mg, 200 Capsules per bottle, Rx Only. Manufacture (February 13, 2018)
  • D-1030-2016 Class II — Nitrofurantoin Oral Suspension, USP, 25 mg/5 mL, FOR ORAL USE ONLY, URINARY TRAC (May 23, 2016)