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 serious injury, meeting the criteria for a Severe rating.
Plain-English summary
Teva Pharmaceuticals USA is recalling MethyIPREDNISolone Acetate Injectable Suspension USP, 400 mg/10 mL (40 mg/mL), 10 mL Multiple-Dose Vials. The recall involves Lot # 31327725B with an expiration date of 02/2021 and Lot # 31327906B with an expiration date of 03/2021. The product is identified by NDC 0703-0045-01.
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 affected product was distributed nationwide in the USA and Puerto Rico. Healthcare providers and patients should stop using the recalled lots and contact Teva Pharmaceuticals USA for further instructions.
The recalled product
- Product
- MethyIPREDNISolone Acetate Injectable Suspension USP, 400 mg/10 mL (40 mg/mL), 10 mL Multiple-Dose Vial, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0703-0045-01.
- Manufacturer
- Teva Pharmaceuticals USA
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 # 31327725B
- exp. date 02/2021 Lot # 31327906B
- exp. date 03/2021
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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