Home / Recalls / THE COMPOUNDING SHOP, INC. / D-569-2013

D-569-2013 Class II Terminated

Recalled by THE COMPOUNDING SHOP, INC. — St Petersburg, FL

FDA drug recall D-569-2013 was initiated by THE COMPOUNDING SHOP, INC. on May 2, 2013 and is designated Class II. Reason for recall: Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes The recall status is terminated (terminated Sep 30, 2024). Affected quantity: 1 vial of 40ml.

Recall Details

Product Type: Drugs
Report Date: Jun 12, 2013
Initiation Date: May 2, 2013
Termination Date: Sep 30, 2024
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 1 vial of 40ml

Product Description

Carnosine 5% Opth drop, 40 mL vial, compounded by The Compounding Shop, St. Petersburg, FL

Reason for Recall

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

Distribution Pattern

Florida, California, Minnesota, and Maine

Code Information

All Lots

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-569-2013
openFDA file date: Oct 26, 2026
Loaded by RegDataLab: Oct 27, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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