Why it was recalled
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
Lot numbers, UPCs & expiration codes
Lots: CCC210008, CCC210009, Exp. 01/23
Where it was sold
Alabama
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0790-2022
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Apr 12, 2022
- FDA report date
- May 4, 2022
- Quantity
- 97,975 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- American Health Packaging
Original FDA data
Every field from FDA enforcement report D-0790-2022, exactly as published.
Show all FDA fields
- City
- Columbus
- State
- OH
- Status
- Terminated
- Country
- United States
- Event ID
- 90003
- Address
- 2550 John Glenn Ave Ste A
- Code information
- Lots: CCC210008, CCC210009, Exp. 01/23
- Postal code
- 43217-1188
- Report date
- May 4, 2022
- Product type
- Drugs
- Recall number
- D-0790-2022
- Classification
- Class III
- Recalling firm
- American Health Packaging
- Product quantity
- 97,975 vials
- Termination date
- Dec 28, 2022
- Reason for recall
- Subpotent Drug: Out of specification for assay.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Recall initiation date
- Apr 12, 2022
- Initial firm notification
- Letter
- Center classification date
- Apr 26, 2022