FindMyRecallSubscribe
Class II: temporary or reversible health riskTerminated

The Compounding Shop B-Complex 100 mg/mL Injectable Recall

B-Complex 100 mg/mL Injectable, 50 mL vials, compounded by The Compounding Shop, St

THE COMPOUNDING SHOP, INC. · St Petersburg, FL

Risk level
Class II
Reported by FDA
Jun 12, 2013
Recall ID
D-564-2013
Check your lot numberHow we source this data

Summary

The Compounding Shop recalled B-Complex 100 mg/mL Injectable starting May 2, 2013. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-564-2013 on Jun 12, 2013. Reason: Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. Status: Terminated.

Why it was recalled

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes

Product description

B-Complex 100 mg/mL Injectable, 50 mL vials, compounded by The Compounding Shop, St. Petersburg, FL

Lot numbers, UPCs & expiration codes

All Lots

Where it was sold

Florida, California, Minnesota, and Maine

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-564-2013
Classification
Class II
Status
Terminated
Recall initiated
May 2, 2013
FDA report date
Jun 12, 2013
Quantity
56 vials of 50mL
Recall type
Voluntary: Firm initiated
Recalling firm
THE COMPOUNDING SHOP, INC.

Original FDA data

Every field from FDA enforcement report D-564-2013, exactly as published.

Show all FDA fields
City
St Petersburg
State
FL
Status
Terminated
Country
United States
Event ID
65125
Address
4000 Park St N
Code information
All Lots
Postal code
33709-4034
Report date
Jun 12, 2013
Product type
Drugs
Recall number
D-564-2013
Classification
Class II
Recalling firm
THE COMPOUNDING SHOP, INC.
Product quantity
56 vials of 50mL
Termination date
Sep 30, 2024
Reason for recall
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Voluntary / mandated
Voluntary: Firm initiated
Product description
B-Complex 100 mg/mL Injectable, 50 mL vials, compounded by The Compounding Shop, St. Petersburg, FL
Distribution pattern
Florida, California, Minnesota, and Maine
Recall initiation date
May 2, 2013
Initial firm notification
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Center classification date
Jun 4, 2013

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-564-2013, published Jun 12, 2013. 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.

How we source and update recall data · Report incorrect information

Other recent drug recalls