Multi-event December 2021 FDA Recall Drug by Valgene Incorporated Dba Cape Drugs

This Multi-event Class II drug recall was voluntarily initiated by Valgene Incorporated Dba Cape Drugs on December 3, 2021 for the product Drug. The FDA reported the reason for recall as lack of processing controls. The product was distributed in Maryland Only and the recall is currently terminated.

Reported Recall Events

D-0283-2022 TERMINATED D-0284-2022 TERMINATED

Recall Number: D-0283-2022

Reason for Recall
Lack of Processing Controls
Initiated
12-03-2021
Reported
12-22-2021
Quantity
27 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89209
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Valgene Incorporated dba Cape Drugs
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Maryland Only
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-04-2022
Product Description About Product Description
Full technical description of the product.
Methylcobalamin 12mg/ml injection, 1 mL vials, Rx only, Cape Drugs 1384 Cape St. Claire Road Annapolis, MD 21409

Batch or Lot Expiration Information

Lot# : 188008, BUD 03/19/2022

Recall Number: D-0284-2022

Reason for Recall
Lack of Processing Controls
Initiated
12-03-2021
Reported
12-22-2021
Quantity
12 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89209
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Valgene Incorporated dba Cape Drugs
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Maryland Only
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-04-2022
Product Description About Product Description
Full technical description of the product.
B-Complex, injection, 1 mL vials, Rx only, Cape Drugs 1384 Cape St. Claire Road Annapolis, MD 21409

Batch or Lot Expiration Information

Lot# 190036, BUD 12/27/2021