Class III
Terminated
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
This recall has been terminated (originally issued August 20, 2014).
- Company
- Pfizer Inc.
- Recall Initiated
- July 30, 2014
- Posted
- August 20, 2014
- Recall Number
- D-1537-2014
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 93,800 vials
- Firm Location
- New York, NY, United States
- Official Source
- View on FDA website ↗
Reason for Recall
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
Distribution
Nationwide
Lot / Code Info
Lot H43272, H43265 Exp. 09/14
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