Cyanocobalamin Injection Recalled Due to Subpotency and Assay Non-Compliance
American Health Packaging is recalling Cyanocobalamin Injection because the product contains insufficient active ingredient and is out of specification for assay. The recalled lots (CCC210008, CCC210009) were distributed in Alabama.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class III recall with no reported illnesses or injuries. The subpotency issue represents a product quality and efficacy concern rather than a direct safety hazard. Consequently, this meets the threshold for a Moderate severity rating per the rubric that indicates FDA Class III recalls are typically scored 1 or 2.
Plain-English summary
American Health Packaging is recalling Cyanocobalamin Injection, USP, 1000 mcg per mL, because the product is subpotent—its active ingredient concentration is below the specified level. The product is manufactured by Eugia Pharma Specialties Limited (Hyderabad, India) for BluePoint Laboratories.
Affected lots CCC210008 and CCC210009 (expiring January 2023) comprise approximately 97,975 vials that were distributed in Alabama. The product is supplied in cartons of 25 vials, with NDC numbers 68001-509-60 (carton) and 68001-509-59 (vial).
This is an FDA Class III drug recall.
The recalled product
- 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
- Manufacturer
- American Health Packaging
- Category
- Drug — Vitamin B12
- Hazard
- Affected units
- 97,975
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lots: CCC210008
- CCC210009
- Exp. 01/23
Distribution
Distributed in 1 state:
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