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Class II: temporary or reversible health riskTerminated

The Compounding Shop Carnosine 5% Opth drop Recall

Carnosine 5% Opth drop, 40 mL vial, 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-569-2013
Check your lot numberHow we source this data

Summary

The Compounding Shop recalled Carnosine 5% Opth drop starting May 2, 2013. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-569-2013 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

Carnosine 5% Opth drop, 40 mL vial, 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-569-2013
Classification
Class II
Status
Terminated
Recall initiated
May 2, 2013
FDA report date
Jun 12, 2013
Quantity
1 vial of 40ml
Recall type
Voluntary: Firm initiated
Recalling firm
THE COMPOUNDING SHOP, INC.

Original FDA data

Every field from FDA enforcement report D-569-2013, 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-569-2013
Classification
Class II
Recalling firm
THE COMPOUNDING SHOP, INC.
Product quantity
1 vial of 40ml
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
Carnosine 5% Opth drop, 40 mL vial, 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-569-2013, 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.

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