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Class II: temporary or reversible health riskTerminated

Valgene Incorporated dba Cape Drugs Methylcobalamin 12mg/ml injection Recall

Methylcobalamin 12mg/ml injection, 1 mL vials, Rx only, Cape Drugs 1384 Cape St

Valgene Incorporated dba Cape Drugs · Annapolis, MD

Risk level
Class II
Reported by FDA
Dec 22, 2021
Recall ID
D-0283-2022
Check your lot numberHow we source this data

Summary

Valgene Incorporated dba Cape Drugs recalled Methylcobalamin 12mg/ml injection starting Dec 3, 2021. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0283-2022 on Dec 22, 2021. Reason: Lack of Processing Controls. Status: Terminated.

Why it was recalled

Lack of Processing Controls

Product description

Methylcobalamin 12mg/ml injection, 1 mL vials, Rx only, Cape Drugs 1384 Cape St. Claire Road Annapolis, MD 21409

Lot numbers, UPCs & expiration codes

Lot #: 188008, BUD 03/19/2022

Where it was sold

Maryland Only

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0283-2022
Classification
Class II
Status
Terminated
Recall initiated
Dec 3, 2021
FDA report date
Dec 22, 2021
Quantity
27 vials
Recall type
Voluntary: Firm initiated
Recalling firm
Valgene Incorporated dba Cape Drugs

Original FDA data

Every field from FDA enforcement report D-0283-2022, exactly as published.

Show all FDA fields
City
Annapolis
State
MD
Status
Terminated
Country
United States
Event ID
89209
Address
1384 Cape St Claire Rd
Code information
Lot #: 188008, BUD 03/19/2022
Postal code
21409-5325
Report date
Dec 22, 2021
Product type
Drugs
Recall number
D-0283-2022
Classification
Class II
Recalling firm
Valgene Incorporated dba Cape Drugs
Product quantity
27 vials
Termination date
Jan 4, 2022
Reason for recall
Lack of Processing Controls
Voluntary / mandated
Voluntary: Firm initiated
Product description
Methylcobalamin 12mg/ml injection, 1 mL vials, Rx only, Cape Drugs 1384 Cape St. Claire Road Annapolis, MD 21409
Distribution pattern
Maryland Only
Recall initiation date
Dec 3, 2021
Initial firm notification
Telephone
Center classification date
Dec 15, 2021

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0283-2022, published Dec 22, 2021. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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