FDA Drug recall D-0703-2017
PrednisoLONE Oral Solution USP, 15 mg/5mL, alcohol content: 5%(v/v) 240 mL bottle, Rx Only, Manufactured in Canada By: CONTRACT PHARMACEUTI…
- FDA Drug
- Class III
- terminated
- Published 2017-05-17
On 2017-05-17 the FDA classified a Class III recall of PrednisoLONE Oral Solution USP, 15 mg/5mL, alcohol content: 5%(v/v) 240 mL bottle, Rx Only, Manufactured in Canada By: CONTRACT PHARMACEUTI… by Teva Pharmaceuticals Usa, citing failed Stability Specifications.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0703-2017 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2017-03-28 |
| Published | 2017-05-17 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Teva Pharmaceuticals Usa |
| Distribution | US |
Product
PrednisoLONE Oral Solution USP, 15 mg/5mL, alcohol content: 5%(v/v) 240 mL bottle, Rx Only, Manufactured in Canada By: CONTRACT PHARMACEUTICALS LIMITED CANADA, Ontario, Canada, L5N 6L6, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960, NDC 0093-6118-87
Reason
Failed Stability Specifications
Identifiers
| code_info | Lot # 94358; Exp. 05/17 Lot # 94920A; Exp. 07/17 Lot # 97083A; Exp. 12/17 |
|---|
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-0703-2017%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.