PlainRecalls
FDA Drug Low Class III Terminated

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

Reported: May 4, 2022 Initiated: April 12, 2022 #D-0790-2022

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

Reason for Recall

Subpotent Drug: Out of specification for assay.

Details

Recalling Firm
American Health Packaging
Units Affected
97,975 vials
Distribution
Alabama
Location
Columbus, OH

Frequently Asked Questions

What product was recalled?
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. Recalled by American Health Packaging. Units affected: 97,975 vials.
Why was this product recalled?
Subpotent Drug: Out of specification for assay.
Which agency issued this recall?
This recall was issued by the FDA Drug on May 4, 2022. Severity: Low. Recall number: D-0790-2022.