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.
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: 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
Same manufacturer · Valgene Incorporated dba Cape Drugs
See all →- ModerateB-Complex Injection Recalled Due to Lack of Processing Controls
FDA (Drugs) · 2021-12-22
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