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
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
Lot numbers, UPCs & expiration codes
Lot H43272, H43265 Exp. 09/14
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1537-2014
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jul 30, 2014
- FDA report date
- Aug 20, 2014
- Quantity
- 93,800 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Pfizer Inc.
Original FDA data
Every field from FDA enforcement report D-1537-2014, exactly as published.
Show all FDA fields
- City
- New York
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 68876
- Address
- 235 East 42nd Street
- Code information
- Lot H43272, H43265 Exp. 09/14
- Postal code
- 10017-5703
- Report date
- Aug 20, 2014
- Product type
- Drugs
- Recall number
- D-1537-2014
- Classification
- Class III
- Recalling firm
- Pfizer Inc.
- Product quantity
- 93,800 vials
- Termination date
- Mar 22, 2017
- 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
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide
- Recall initiation date
- Jul 30, 2014
- Initial firm notification
- Letter
- Center classification date
- Aug 12, 2014