Teva Recalls MethyIPREDNISolone Acetate Injectable Suspension Due to Sterility Concerns
Teva Pharmaceuticals is recalling 15,043 vials 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 FDA classified this as a Class II recall. Per the rubric, FDA Class II recalls involving significant injury/property-damage reports or high-risk pathogens (like sterility failures in injectables) are typically scored as Severe (4), especially when the defect is structural or fundamental to the product's safety profile (sterility).
Plain-English summary
Teva Pharmaceuticals USA, Inc. is recalling 15,043 vials of MethyIPREDNISolone Acetate Injectable Suspension USP, 400 mg/5 mL (80 mg/mL), 5 mL Multiple-Dose Vial. The product is identified by Lot # 31327738B with an expiration date of 03/2021. The recall is due to a lack of assurance of sterility, as manufacturing areas for the product exceeded acceptance levels for microbial recovery.
The affected product was distributed nationwide in the USA and Puerto Rico. This is a prescription-only medication (Rx only) manufactured by Teva Pharmaceuticals USA, Inc. in North Wales, PA.
Healthcare providers and patients should discontinue use of the recalled product and contact their healthcare provider for further instructions. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- MethyIPREDNISolone Acetate Injectable Suspension USP, 400 mg/5 mL (80 mg/mL), 5 mL Multiple-Dose Vial, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0703-0063-01.
- Manufacturer
- Teva Pharmaceuticals USA
- Affected units
- 15,043
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 (2)
- Lot # 31327738B
- 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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