Methylprednisolone Acetate Injectable Suspension recalled for sterility concerns
Teva Pharmaceuticals is recalling Methylprednisolone Acetate Injectable Suspension USP 80 mg/mL due to lack of assurance of sterility. The recall affects single-dose and multi-dose vials distributed nationwide, including Puerto Rico.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this as a Class II recall. Lack of sterility assurance in an injectable pharmaceutical product poses a significant risk of serious infection or injury if the product is used, meeting the Severe (Class II) criterion in the rubric.
Plain-English summary
Teva Pharmaceuticals USA is recalling Methylprednisolone Acetate Injectable Suspension USP, 80 mg/mL, distributed nationwide and in Puerto Rico. The recall applies to two product configurations: 1 mL single-dose vials (NDC 0703-0051-01) and 5 mL multi-dose vials (NDC 0703-0063-01). A total of 50,713 vials are affected.
The recall is due to lack of assurance of sterility. Affected lot numbers are: for single-dose vials, lot #31329363B (expiration 01/2022) and lot #31329484B (expiration 03/2022); for multi-dose vials, lot #31328367B and lot #31328431B (expiration 07/2021) and lot #31329014B (expiration 11/2021).
Consumers and healthcare providers who have received this product should discontinue use immediately. Contact Teva Pharmaceuticals USA at North Wales, PA 19454, or consult with a healthcare provider regarding appropriate action. The product is prescription-only.
The recalled product
- Product
- 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.
- Manufacturer
- Teva Pharmaceuticals USA
- Affected units
- 50,713
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (8)
- Lot #: a) 31329363B
- exp. date 01/2022
- 31329484B
- exp. date 03/2022 b) 31328367B
- 31328431B
- exp. date 07/2021
- 31329014B
- exp. date 11/2021
Distribution
Part of a larger recall action
This product is one of 19 recalled by Teva Pharmaceuticals USA under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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