Medications & Supplements/Prescription Drugs

BluePoint Laboratories Cyanocobalamin Injection Recalled for Subpotency

Agency Publication Date: April 26, 2022

Summary

BluePoint Laboratories is recalling 97,975 vials of Cyanocobalamin Injection, USP (Vitamin B12), 1000 mcg per mL. This prescription medication, which is used to treat vitamin deficiencies, was found to be subpotent, meaning it contains less than the required amount of the active ingredient. No incidents or injuries have been reported to date. This recall affects vials distributed in Alabama.

Risk

Patients using the subpotent injection may not receive the full intended dose of Vitamin B12, which can result in ineffective treatment of vitamin deficiencies or related medical conditions.

What You Should Do

This recall affects Cyanocobalamin Injection, USP (1000 mcg per mL) sold in 25 x 1 mL vials under the BluePoint Laboratories brand. Affected products are identified by NDC codes 68001-509-59 (vial) or 68001-509-60 (carton) with lot numbers CCC210008 or CCC210009 and an expiration date of 01/23.
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact American Health Packaging for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Cyanocobalamin Injection, USP (1000 mcg per mL)

Variants: 1000 mcg per mL, 25 x 1 mL Vials, For Intramuscular or Subcutaneous Use Only, Rx only

Lot Numbers:

CCC210008 (Exp. 01/23)

CCC210009 (Exp. 01/23)

NDC:

68001-509-60

68001-509-59

Manufactured by Eugia Pharma Specialties Limited for BluePoint Laboratories.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 90003

Status: Resolved

Manufacturer: American Health Packaging

Sold By: BluePoint Laboratories

Manufactured In: India, United States

Units Affected: 97,975 vials

Distributed To: Alabama

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall affects Cyanocobalamin Injection, USP (1000 mcg per mL) sold in 25 x 1 mL vials under the BluePoint Laboratories brand. Affected products are identified by NDC codes 68001-509-59 (vial) or 68001-509-60 (carton) with lot numbers CCC210008 or CCC210009 and an expiration date of 01/23.

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact American Health Packaging for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Cyanocobalamin Injection, USP (1000 mcg per mL)

Variants: 1000 mcg per mL, 25 x 1 mL Vials, For Intramuscular or Subcutaneous Use Only, Rx only

Lot Numbers:

CCC210008 (Exp. 01/23)

CCC210009 (Exp. 01/23)

NDC:

68001-509-60

68001-509-59

Manufactured by Eugia Pharma Specialties Limited for BluePoint Laboratories.