Recalls / Class III
Class IIID-1537-2014
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
- Brand name
- Depo-medrol
- Generic name
- Methylprednisolone Acetate
- Active ingredient
- Methylprednisolone Acetate
- Route
- Intra-articular, Intralesional, Intramuscular, Soft Tissue, Intrasynovial
- NDCs
- 0009-3073, 0009-3475
- FDA application
- NDA011757
- Affected lot / code info
- Lot H43272, H43265 Exp. 09/14
Why it was recalled
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
Recalling firm
- Firm
- Pfizer Inc.
- Manufacturer
- Pharmacia & Upjohn Company LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 235 East 42nd Street, N/A, New York, New York 10017-5703
Distribution
- Quantity
- 93,800 vials
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2014-07-30
- FDA classified
- 2014-08-12
- Posted by FDA
- 2014-08-20
- Terminated
- 2017-03-22
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1537-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.