The Recall Desk
ModerateFDA (Drugs)·D-0284-2022·Announced 2021-12-22

B-Complex Injection Recalled Due to Lack of Processing Controls

Valgene Incorporated dba Cape Drugs is recalling B-Complex injection in 1 mL vials (Lot# 190036, BUD 12/27/2021) distributed in Maryland due to lack of processing controls.

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: This is an FDA Class II recall with no reported illnesses or injuries stated in the source text. The hazard—lack of processing controls—is a manufacturing deficiency that presents a potential risk but has not resulted in documented harm. Per the rubric, Class II recalls without reported hospitalization or significant injury are classified as Moderate.

Plain-English summary

Valgene Incorporated dba Cape Drugs is recalling B-Complex injection, 1 mL vials, Rx only, due to lack of processing controls. The affected lot is Lot# 190036 with a Beyond Use Date of 12/27/2021.

This product was distributed in Maryland only. The recall affects 12 vials of the affected lot.

Consumers or healthcare providers who have received this product should contact Valgene Incorporated dba Cape Drugs or consult with a healthcare professional regarding appropriate steps to take.

The recalled product

Product
B-Complex, 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
Hazard
  • manufacturing-defect
  • processing-control-failure

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# 190036
  • BUD 12/27/2021

Distribution

Distribution scope not specified by the agency.

Related recalls

Same category