Home / Recalls / American Health Packaging / D-1003-2020

D-1003-2020 Class II Terminated

Recalled by American Health Packaging — Columbus, OH

Recall Details

Product Type
Drugs
Report Date
March 18, 2020
Initiation Date
November 20, 2019
Termination Date
August 4, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
53,619 cartons

Product Description

Ranitidine Tablets, USP, 150 mg, 100 Tablets (10 tablets x 10 blister card), Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC carton: 60687-322-01; NDC Unit Dose Card: 60687-322-11

Reason for Recall

CGMP Deviations: Potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA.

Distribution Pattern

Nationwide USA

Code Information

Lot, expiry: Lots 179516, 179745, exp 12/31/2019; Lot 180712, exp 02/29/2020; Lot 180819, exp 04/30/2020; Lots 181403, 182544, 183155, 183236, exp 05/31/2020; Lots 185739, 186600, 186702, exp 12/31/2020

Other recalls by American Health Packaging

  • D-0880-2022 Class III — Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals), 100 mg, 100 Capsules ( (May 3, 2022)
  • 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)