Recalls / Class III
Class IIID-0790-2022
Product
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
- Affected lot / code info
- Lots: CCC210008, CCC210009, Exp. 01/23
Why it was recalled
Subpotent Drug: Out of specification for assay.
Recalling firm
- Firm
- American Health Packaging
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2550 John Glenn Ave Ste A, Columbus, Ohio 43217-1188
Distribution
- Quantity
- 97,975 vials
- Distribution pattern
- Alabama
Timeline
- Recall initiated
- 2022-04-12
- FDA classified
- 2022-04-26
- Posted by FDA
- 2022-05-04
- Terminated
- 2022-12-28
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0790-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.