July 2014 FDA Recall Depo-medrol by Pfizer Inc.
D-1537-2014 - Failed pH Specification

This Class III drug recall was voluntarily initiated by Pfizer Inc. on July 30, 2014 for the product Depo-medrol. The FDA reported the reason for recall as failed ph specification. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1537-2014

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
Initiated
07-30-2014
Reported
08-20-2014
Quantity
93,800 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
68876
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Pfizer Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-22-2017
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

Lot# Lot H43272, H43265 Exp. 09/14

Affected Packages Involved in this Recall

0009-3073-01 Depo-medrol
0009-3073-03 Depo-medrol
0009-3475-01 Depo-medrol
0009-3475-03 Depo-medrol
0009-3073-22 Depo-medrol
0009-3073-23 Depo-medrol
0009-3475-22 Depo-medrol
0009-3475-23 Depo-medrol