FDA Drug recall D-1537-2014
Depo-Medrol (methylprednisolone acetate injectable suspension USP), 40 mg/ mL, 1 mL Single-Dose Vial, Rx only, Distributed by Pharmacia & U…
- FDA Drug
- Class III
- terminated
- Published 2014-08-20
On 2014-08-20 the FDA classified a Class III recall of Depo-Medrol (methylprednisolone acetate injectable suspension USP), 40 mg/ mL, 1 mL Single-Dose Vial, Rx only, Distributed by Pharmacia & U… by Pfizer, citing failed pH Specification: A pH result of 2.9 was obtained at the 9 month stability test interval at 25C/60%RH. The registered specification for pH is 3.0 - 7.0.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1537-2014 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2014-07-30 |
| Published | 2014-08-20 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Pfizer |
| Distribution | US |
Product
Depo-Medrol (methylprednisolone acetate injectable suspension USP), 40 mg/ mL, 1 mL Single-Dose Vial, Rx only, Distributed by Pharmacia & Upjohn Co Division of Pfizer Inc, New York NY 10017 NDC 0009-3073-03 DEPO-MEDROL methylprednisolone acetate Injectable Suspension USP, 40 mg per mL, 1 mL Single-Dose Vial, Rx ONLY, Distributed by Pharmacia & Upjohn Co Division of Pfizer Inc, New York NY 10017, NOVAPLUS is a registered trademark of Novation, LLC NDC 0009-3073-23
Reason
Failed pH Specification: A pH result of 2.9 was obtained at the 9 month stability test interval at 25C/60%RH. The registered specification for pH is 3.0 - 7.0
Identifiers
| ndc | 0009-3073-01 |
|---|---|
| ndc | 0009-3073-03 |
| ndc | 0009-3475-01 |
| ndc | 0009-3475-03 |
| ndc | 0009-3073-22 |
| ndc | 0009-3073-23 |
| ndc | 0009-3475-22 |
| ndc | 0009-3475-23 |
| code_info | Lot H43272, H43265 Exp. 09/14 |
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-1537-2014%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.