Methylprednisolone Acetate Injectable Suspension USP, 80 mg/mL, packaged in a) 1 mL Single-Dose vials (0703-0051-01), and b) 5mL Multi Dose Vials (NDC 0703-0063-01), Rx only, TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454.
Reported: August 25, 2021 Initiated: July 29, 2021 #D-0743-2021
Product Description
Methylprednisolone Acetate Injectable Suspension USP, 80 mg/mL, packaged in a) 1 mL Single-Dose vials (0703-0051-01), and b) 5mL Multi Dose Vials (NDC 0703-0063-01), Rx only, TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454.
Reason for Recall
Lack of Assurance of Sterility
Details
- Recalling Firm
- Teva Pharmaceuticals USA
- Units Affected
- 50,713 vials
- Distribution
- Product was distributed Nationwide, including Puerto Rico.
- Location
- Parsippany, NJ
Frequently Asked Questions
What product was recalled? ▼
Methylprednisolone Acetate Injectable Suspension USP, 80 mg/mL, packaged in a) 1 mL Single-Dose vials (0703-0051-01), and b) 5mL Multi Dose Vials (NDC 0703-0063-01), Rx only, TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454.. Recalled by Teva Pharmaceuticals USA. Units affected: 50,713 vials.
Why was this product recalled? ▼
Lack of Assurance of Sterility
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 25, 2021. Severity: Moderate. Recall number: D-0743-2021.
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