Why it was recalled
Lack of Assurance of Sterility
Product description
MethylPREDNISolone Acetate Injectable Suspension USP 400 mg/10mL (40mg/mL), 10 mL Multiple-Dose Vial, Rx Only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured By: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, NDC 16714-090-01, packaged in cartons.
Lot numbers, UPCs & expiration codes
Lot # 100022393, exp 09/2022
Where it was sold
Methylprednisolone, TN Norepinephrine BItartrate - MS, OH
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-0370-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Dec 31, 2021
- FDA report date
- Jan 19, 2022
- Quantity
- 7,400 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teva Pharmaceuticals USA
Original FDA data
Every field from FDA enforcement report D-0370-2022, exactly as published.
Show all FDA fields
- City
- Parsippany
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 89326
- Address
- 400 Interpace Pkwy
- Code information
- Lot # 100022393, exp 09/2022
- Postal code
- 07054-1120
- Report date
- Jan 19, 2022
- Product type
- Drugs
- Recall number
- D-0370-2022
- Classification
- Class II
- Recalling firm
- Teva Pharmaceuticals USA
- Product quantity
- 7,400 cartons
- 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 400 mg/10mL (40mg/mL), 10 mL Multiple-Dose Vial, Rx Only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured By: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, NDC 16714-090-01, packaged in cartons.
- Distribution pattern
- Methylprednisolone, TN Norepinephrine BItartrate - MS, OH
- Recall initiation date
- Dec 31, 2021
- Initial firm notification
- Letter
- Center classification date
- Jan 13, 2022