The Recall Desk
ModerateFDA (Drugs)·D-0283-2022·Announced 2021-12-22

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
Hazard
  • manufacturing-defect
  • lack-of-process-control

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

Distribution scope not specified by the agency.

Related recalls

Same category