Cyanocobalamin Injection Recalled for Subpotent Drug - Out of Specification Assay
Aurobindo Pharma USA Inc. is recalling 433,809 vials of Cyanocobalamin injection nationwide because assay testing showed the drug is subpotent, containing less than the specified 1,000 mcg/mL of active ingredient. Affected lots with specific expiration dates from September 2022 to April 2023 are identified for recall.
What this means for you
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: FDA Class III recall of a subpotent drug with no reported illnesses or injuries. According to the severity rubric, Class III recalls are typically scored 1-2; this is a manufacturing/quality defect rather than an acute safety hazard, warranting a Moderate (2) severity score.
Plain-English summary
Aurobindo Pharma USA Inc. is recalling Cyanocobalamin (Vitamin B12) Injection, USP, 1,000 mcg/mL, across the United States. The recall affects 433,809 vials distributed nationwide. Specific lot numbers with expiration dates from September 2022 through April 2023 are included in this recall.
The recall was initiated because quality control testing found that the drug is subpotent, containing less than the specified 1,000 mcg/mL of cyanocobalamin per mL. This out-of-specification assay result was identified during manufacturing quality testing.
Healthcare providers should check medication records for patients who may have received affected lots. Patients with questions about their treatment should contact their healthcare provider or pharmacist. No illnesses or injuries related to this product have been reported to the FDA.
The recalled product
- Product
- CYANOCOBALAMIN (CYANOCOBALAMIN)
- Brand
- CYANOCOBALAMIN
- Manufacturer
- Aurobindo Pharma USA Inc.
- Category
- Drug — Injectable Vitamin B12
- Hazard
- subpotent
- potency-deficiency
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 (9)
- Lots: CCC210004
- Exp 09/2022
- CCC210005
- CCC210006
- CCC210007
- Exp 11/2022
- CCC210010
- CCC210011
- Exp 04/2023.
UPCs (2)
- 0355150364015
- 0355150364107
Distribution
Distributed nationwide across the United States.
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