Drug recall D-1537-2014

Class III Terminated reported Aug 20, 2014

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 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

Lots and codes

Lot H43272, H43265 Exp. 09/14

Recall details

Recalling firm
Pfizer Inc., New York, NY
Quantity
93,800 vials
Distribution
Nationwide
Type
Voluntary: Firm initiated
Recall initiated
July 30, 2014
Terminated
March 22, 2017

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