FindMyRecallSubscribe
Class III: unlikely to cause harmTerminated

American Health Packaging Cyanocobalamin Injection Recall

Cyanocobalamin Injection, USP, 1000 mcg per mL, For Intramuscular or Subcutaneous Use O…

American Health Packaging · Columbus, OH

Risk level
Class III
Reported by FDA
May 4, 2022
Recall ID
D-0790-2022
Check your lot numberHow we source this data

Summary

American Health Packaging recalled Cyanocobalamin Injection starting Apr 12, 2022. The FDA classified it as Class III (unlikely to cause harm) and published enforcement report D-0790-2022 on May 4, 2022. Reason: Subpotent Drug: Out of specification for assay. Status: Terminated.

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

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0790-2022, published May 4, 2022. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

How we source and update recall data · Report incorrect information

Other recent drug recalls