Depo-medrol Injection, Suspension
FDA Recall NDC 0009-3073
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 3 recorded enforcement report(s) associated with Depo-medrol (NDC 0009-3073). A significant event, classified as Class II, was initiated on Apr 13, 2022 by Pharmacia & Upjohn Company Llc. The reported reason for this action was: "cGMP deviations: Temperature abuse"
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
cGMP deviations: Temperature abuse
Apr 13, 2022
Jun 15, 2022
177 cartons
Recall Profile & Regulatory Data
Event ID
89646
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
USA nationwide.
Termination Date
Nov 30, 2023
Product Description
Depo-Medrol (methylprednisolone acetate injectable suspension, USP) 80mg/mL, packaged in a) 1 mL single-dose vial (NDC# 0009-3475-01), b) 25-count box (NDC 0009-3475-03), Rx only, MFG: Pfizer
Batch or Lot Expiration Information
Lot# McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.
Affected Packages Involved in this Recall
0009-3073-01Product
0009-3073-03Product
0009-3475-01Product
0009-3475-03Product
Class II Terminated
cGMP deviations: Temperature abuse
Apr 13, 2022
Jun 15, 2022
2 cartons
Recall Profile & Regulatory Data
Event ID
89646
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
USA nationwide.
Termination Date
Nov 30, 2023
Product Description
Depo-Medrol (methylprednisolone acetate injectable suspension, USP) 40 mg/mL, 1 mL single-dose vial, Rx only, MFG: Pfizer, NDC 0009-3073-03
Batch or Lot Expiration Information
Lot# McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.
Affected Packages Involved in this Recall
0009-3073-01Product
0009-3073-03Product
0009-3475-01Product
0009-3475-03Product
Class III Terminated
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
Jul 30, 2014
Aug 20, 2014
93,800 vials
Recall Profile & Regulatory Data
Event ID
68876
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Pfizer Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Mar 22, 2017
Product Description
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
0009-3073-01Product
0009-3073-03Product
0009-3475-01Product
0009-3475-03Product
0009-3073-22Product
0009-3073-23Product
0009-3475-22Product
0009-3475-23Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
