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Class II: temporary or reversible health riskTerminated

Promise Pharmacy Methylcobalamin lyophilized Recall

Methylcobalamin lyophilized, 10,000 mcg Injection, Rx Only, Promise Pharmacy Compoundin…

Promise Pharmacy, LLC · Palm Harbor, FL

Risk level
Class II
Reported by FDA
Feb 20, 2019
Recall ID
D-0443-2019
Check your lot numberHow we source this data

Summary

Promise Pharmacy recalled Methylcobalamin lyophilized starting Dec 17, 2018. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0443-2019 on Feb 20, 2019. Reason: Lack of sterility assurance. Status: Terminated.

Why it was recalled

Lack of sterility assurance.

Product description

Methylcobalamin lyophilized, 10,000 mcg Injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684

Lot numbers, UPCs & expiration codes

Lots: 08032018@3 BUD: 01/30/2019; 08272018@6 BUD: 2/23/2019; 09142018@4 BUD: 3/13/2019; 10012018@3 BUD: 3/30/2019

Where it was sold

Nationwide in the USA.

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-0443-2019
Classification
Class II
Status
Terminated
Recall initiated
Dec 17, 2018
FDA report date
Feb 20, 2019
Quantity
704 vials
Recall type
Voluntary: Firm initiated
Recalling firm
Promise Pharmacy, LLC

Original FDA data

Every field from FDA enforcement report D-0443-2019, exactly as published.

Show all FDA fields
City
Palm Harbor
State
FL
Status
Terminated
Country
United States
Event ID
81810
Address
31818 Us Highway 19 N
Code information
Lots: 08032018@3 BUD: 01/30/2019; 08272018@6 BUD: 2/23/2019; 09142018@4 BUD: 3/13/2019; 10012018@3 BUD: 3/30/2019
Postal code
34684-3713
Report date
Feb 20, 2019
Product type
Drugs
Recall number
D-0443-2019
Classification
Class II
Recalling firm
Promise Pharmacy, LLC
Product quantity
704 vials
Termination date
Mar 30, 2021
Reason for recall
Lack of sterility assurance.
Voluntary / mandated
Voluntary: Firm initiated
Product description
Methylcobalamin lyophilized, 10,000 mcg Injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Distribution pattern
Nationwide in the USA.
Recall initiation date
Dec 17, 2018
Initial firm notification
Letter
Center classification date
Feb 8, 2019

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0443-2019, published Feb 20, 2019. View the source record (openFDA) · FDA enforcement reports

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

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