Why it was recalled
Lack of Assurance of Sterility
Product description
Methylprednisolone Acetate Injectable Suspension USP, 40 mg/mL, packaged in a) 1 mL Single-Dose vials (0703-0031-01), and b) 5mL Multi Dose Vials (NDC 0703-0043-01), and c) 10 mL Multi-Dose Vials (NDC 0703-0045-01), Rx only, TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454.
Lot numbers, UPCs & expiration codes
Lot #: a) 31328455B, exp. date 09/2021; 31329340B, exp. date 12/2021; 31329439B, exp. date 01/2022; 31328347B, exp. date 07/2021 b) 31328321B, exp. date 07/2021; c) 31328368B, 31328394B, exp. date 07/2021; 31328699B, exp. date 09/2021; 31328834B, exp. date 10/2021; 31329286B, exp. date 12/2021
Where it was sold
Product was distributed Nationwide, including Puerto Rico.
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-0731-2021
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 29, 2021
- FDA report date
- Aug 25, 2021
- Quantity
- 193,845 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teva Pharmaceuticals USA
Original FDA data
Every field from FDA enforcement report D-0731-2021, exactly as published.
Show all FDA fields
- City
- Parsippany
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 88442
- Address
- 400 Interpace Pkwy
- Code information
- Lot #: a) 31328455B, exp. date 09/2021; 31329340B, exp. date 12/2021; 31329439B, exp. date 01/2022; 31328347B, exp. date 07/2021 b) 31328321B, exp. date 07/2021; c) 31328368B, 31328394B, exp. date 07/2021; 31328699B, exp. date 09/2021; 31328834B, exp. date 10/2021; 31329286B, exp. date 12/2021
- Postal code
- 07054-1120
- Report date
- Aug 25, 2021
- Product type
- Drugs
- Recall number
- D-0731-2021
- Classification
- Class II
- Recalling firm
- Teva Pharmaceuticals USA
- Product quantity
- 193,845 vials
- Termination date
- Jun 4, 2024
- Reason for recall
- Lack of Assurance of Sterility
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Methylprednisolone Acetate Injectable Suspension USP, 40 mg/mL, packaged in a) 1 mL Single-Dose vials (0703-0031-01), and b) 5mL Multi Dose Vials (NDC 0703-0043-01), and c) 10 mL Multi-Dose Vials (NDC 0703-0045-01), Rx only, TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454.
- Distribution pattern
- Product was distributed Nationwide, including Puerto Rico.
- Recall initiation date
- Jul 29, 2021
- Initial firm notification
- Letter
- Center classification date
- Aug 16, 2021