American Health Packaging: Drug Recall

Recall #D-0790-2022 · 04/12/2022

Class III: Low Risk

Recall Details

Recall Number: D-0790-2022
Classification: Class III
Product Type: Drug
Recalling Firm: American Health Packaging
Status: Terminated
Date Initiated: 04/12/2022
Location: Columbus, OH, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 97,975 vials

Reason for Recall

Subpotent Drug: Out of specification for assay.

Product Description

Cyanocobalamin Injection, USP, 1000 mcg per mL, For Intramuscular or Subcutaneous Use Only, 25 x 1 mL Vials, Rx only, Manufactured by: Eugia Pharma Specialties Limited, Hyderabad India for BluePoint Laboratories. NDC for Carton: 68001-509-60; NDC for vial: 68001-509-59

Distribution Pattern

Alabama

Other Recalls by American Health Packaging

Class III: Low Risk 05/03/2022

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.
Class II: Risk 02/22/2022

Impurity failure at 0-time of the repackaged lot.
Class II: Risk 12/20/2021

Failed Dissolution Specifications
Class II: Risk 09/17/2021

Failed Dissolution Specifications: results were above specification.
Class II: Risk 09/15/2021

CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.

View all recalls by American Health Packaging →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.