MethyIPREDNISolone Acetate Injectable Suspension USP recall: Sterility Concern
MethyIPREDNISolone Acetate Injectable Suspension USP, 400 mg/10 mL (40 mg/mL), 10 mL Multiple-Dose Vial, Rx only, Teva Pharmaceuticals USA, Inc.…
Why was MethyIPREDNISolone Acetate Injectable Suspension USP recalled?
Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot # 31327725B, exp. date 02/2021 Lot # 31327906B, exp. date 03/2021
- Product
- MethyIPREDNISolone Acetate Injectable Suspension USP, 400 mg/10 mL (40 mg/mL), 10 mL Multiple-Dose Vial, Rx only, Teva Pharmaceuticals USA, Inc.…
- Recalling firm
- Teva Pharmaceuticals USA
- Quantity
- N/A
- Distribution
- Product was distributed nationwide in the USA and Puerto Rico.
- Recall date
- March 3, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)