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.
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: 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
- Affected units
- 12
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
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.
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