Home / Recalls / American Health Packaging / D-0880-2022

D-0880-2022 Class III Terminated

Recalled by American Health Packaging — Columbus, OH

Recall Details

Product Type
Drugs
Report Date
May 25, 2022
Initiation Date
May 3, 2022
Termination Date
September 28, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1603 cartons

Product Description

Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals), 100 mg, 100 Capsules (10 x 10), 10-count blisters per card, 10 cards per carton, Unit Dose NDC 68084-446-11, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC: 68084-446-01

Reason for Recall

Failed Dissolution Specifications: Nitrofurantoin Capsules recalled due to dissolution failure at 0-time of the repackaged lot. Drug release results were above specification at 0-time.

Distribution Pattern

Nationwide USA

Code Information

Lot # 1003829, Exp date 1/31/23

Other recalls by American Health Packaging

  • D-0790-2022 Class III — Cyanocobalamin Injection, USP, 1000 mcg per mL, For Intramuscular or Subcutaneou (April 12, 2022)
  • D-0652-2022 Class II — Oxycodone Hydrochloride Oral Solution, USP (C-II), 5 mg/5 mL, Delivers 5 mL per (February 22, 2022)
  • D-0451-2022 Class II — Metoprolol Succinate Extended-Release Tablets, USP 50 mg, 500-count bottle, Rx O (December 20, 2021)
  • D-0020-2022 Class II — GlipiZIDE Extended-Release Tablets, 2.5 mg, 30 Tablets (3 blister cards each wit (September 17, 2021)
  • D-0854-2021 Class II — Valproic Acid Oral Solution, USP, 500 mg/10 mL, 100 10 mL unit dose cups per cas (September 15, 2021)
  • D-0813-2021 Class III — Sirolimus Tablets 1 mg, 30 Tablets (5 blister cards x 6 unit doses), Rx only, Pa (May 12, 2021)
  • D-0232-2021 Class II — Nitrofurantoin Capsules USP (Monohydrate/Macrocrystals), 100 mg, 100 per carton (January 7, 2021)
  • D-1372-2020 Class III — Nabumetone Tablets, USP, 500 mg, 100 Tablets per carton (10 tablets x 10 blister (June 10, 2020)
  • D-1293-2020 Class II — Doxycycline Hyclate Tablets, USP, 100 mg, 30 Tablets per carton (3 x 10), Rx onl (May 19, 2020)
  • D-0849-2020 Class II — Desmopressin Acetate Tablets, 0.2 mg, 30 tablets (3 x 10 unit dose blister cards (February 7, 2020)