Teva Recalls MethyIPREDNISolone Acetate Injectable Suspension Due to Sterility Concerns
Teva Pharmaceuticals is recalling specific lots of MethyIPREDNISolone Acetate Injectable Suspension because manufacturing areas exceeded microbial acceptance levels, compromising sterility assurance.
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 recall is classified as FDA Class II and involves a lack of sterility assurance in injectable products, which poses a significant risk of infection and potential hospitalization, meeting the criteria for a Severe rating.
Plain-English summary
Teva Pharmaceuticals USA, Inc. is recalling 5,378 vials of MethyIPREDNISolone Acetate Injectable Suspension USP, 80 mg/mL, 1 mL Single-Dose Vials (NDC 0703-0051-01). The affected lots are # 31327909B (exp. 04/2021) and # 31328352B (exp. 07/2021). The product is packaged in 25X1ML vials per tray (NDC 0703-0051-04) and is available by prescription only.
The recall was initiated because manufacturing areas for these products exceeded acceptance levels for microbial recovery. This condition led to a lack of sterility assurance for these sterile injectable products. The FDA has classified this recall as Class II.
The product was distributed nationwide in the USA and Puerto Rico. Healthcare providers and patients should check their inventory and discontinue use of the affected lots. Patients should consult their healthcare provider for alternative treatment options if they have received this medication.
The recalled product
- Product
- MethyIPREDNISolone Acetate Injectable Suspension USP, 80 mg/mL, 1 mL Single-Dose Vial (NDC 0703-0051-01), packaged in 25X1ML vials per tray (NDC 0703-0051-04), Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454.
- Manufacturer
- Teva Pharmaceuticals USA
- Affected units
- 5,378
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 (3)
- Lot # 31327909B
- exp. date 04/2021 Lot # 31328352B
- exp. date 07/2021
Distribution
Part of a larger recall action
This product is one of 15 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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