FDA Drug recall D-551-2013
Baclofen 1,000 mcg/mL Injectable, 20 mL and 40 mL vial, Compounded by The Compounding Shop, St. Petersburg, FL
- FDA Drug
- Class II
- terminated
- Published 2013-06-12
On 2013-06-12 the FDA classified a Class II recall of Baclofen 1,000 mcg/mL Injectable, 20 mL and 40 mL vial, Compounded by The Compounding Shop, St. Petersburg, FL by The Compounding Shop, citing lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-551-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-05-02 |
| Published | 2013-06-12 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | The Compounding Shop |
| Distribution | CA, FL, ME, MN |
Product
Baclofen 1,000 mcg/mL Injectable, 20 mL and 40 mL vial, Compounded by The Compounding Shop, St. Petersburg, FL
Reason
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Identifiers
| code_info | All Lots |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-551-2013%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.