Methylcobalamin Injection Recalled Due to Lack of Processing Controls
Valgene Incorporated, dba Cape Drugs, is recalling Methylcobalamin 12mg/ml injection (Lot #188008) due to lack of processing controls. The recall affects 27 vials distributed in Maryland.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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: The recall is classified as FDA Class II, which typically carries a score of 2 (Moderate) in the absence of reported hospitalizations, serious injuries, or deaths. The hazard—lack of processing controls—is a manufacturing defect without evidence of adverse health outcomes in the source text.
Plain-English summary
Valgene Incorporated, doing business as Cape Drugs, is recalling Methylcobalamin 12mg/ml injection, 1 mL vials, Rx only, because of a lack of processing controls during manufacturing.
The affected product is Lot #188008 with a beyond-use date (BUD) of 03/19/2022. A total of 27 vials were distributed in Maryland only.
This is a Class II recall issued by the U.S. Food and Drug Administration. Patients who have received this product should consult with their healthcare provider about appropriate follow-up care. Healthcare providers and patients should report any adverse events to the FDA's MedWatch program.
The recalled product
- Product
- Methylcobalamin 12mg/ml injection, 1 mL vials, Rx only, Cape Drugs 1384 Cape St. Claire Road Annapolis, MD 21409
- Manufacturer
- Valgene Incorporated dba Cape Drugs
- Category
- Drug — Injectable / Vitamin B12
- Affected units
- 27
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 (2)
- Lot #: 188008
- BUD 03/19/2022
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 2 recalled by Valgene Incorporated dba Cape Drugs under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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