FDA Drug recall D-0681-2017
Methylprednisolone Acetate 40 mg/mL, Lidocaine HCl 10 mg/mL, 10 mL Multi-Dose Vial For Injection, Rx Only, Isomeric Pharmacy Solutions, 240…
- FDA Drug
- Class II
- terminated
- Published 2017-05-03
On 2017-05-03 the FDA classified a Class II recall of Methylprednisolone Acetate 40 mg/mL, Lidocaine HCl 10 mg/mL, 10 mL Multi-Dose Vial For Injection, Rx Only, Isomeric Pharmacy Solutions, 240… by Isomeric Pharmacy Solution, citing lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0681-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-04-06 |
| Published | 2017-05-03 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Isomeric Pharmacy Solution |
| Distribution | US |
Product
Methylprednisolone Acetate 40 mg/mL, Lidocaine HCl 10 mg/mL, 10 mL Multi-Dose Vial For Injection, Rx Only, Isomeric Pharmacy Solutions, 2401 Foothill Drive, SLC, UT 84109, Part # 1010, barcode 3 70285 10101 4.
Reason
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Identifiers
| code_info | Lot #s: 09007, Exp 04/04/17; 09016, Exp 04/16/17; 09020, Exp 04/18/17; 09025, Exp 04/23/17; 10026, 10030, Exp 05/28/17;…Lot #s: 09007, Exp 04/04/17; 09016, Exp 04/16/17; 09020, Exp 04/18/17; 09025, Exp 04/23/17; 10026, 10030, Exp 05/28/17; 11007, Exp 05/30/17; 11008, Exp 05/31/17; 11020, Exp 06/07/17; 11028, Exp 06/12/17; 11043, Exp 06/26/17. |
|---|
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-0681-2017%22
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