Home / Recalls / Nostrum Laboratories Inc / D-1059-2020

D-1059-2020 Class II Terminated

Recalled by Nostrum Laboratories Inc — Kansas City, MO

Recall Details

Product Type
Drugs
Report Date
April 1, 2020
Initiation Date
March 6, 2020
Termination Date
April 1, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
4722 bottles

Product Description

Theophylline (Anhydrous) Extended-Release Tablets, 400 mg, 100-count bottle, Rx Only, Manufactured by: Nostrum Laboratories, Inc., Kansas City, MO 64120, NDC 29033-001-01.

Reason for Recall

CGMP Deviations: poor manufacturing practices resulted in Labeling: Incorrect or Missing Lot and/or Exp Date, product incorrectly labeled with incorrect lot and expiration date.

Distribution Pattern

TN, MO

Code Information

Lot: THE190501, Exp 11/2022

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-0068-2021 Class II — Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, 100 count bottles, (October 23, 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)