Sirolimus Oral Solution recall: Failed Dissolution
Sirolimus Oral Solution, 1 mg/mL, 60 mL bottle, Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp.…
Why was Sirolimus Oral Solution recalled?
Failed Dissolution Specifications: Sirolimus Oral Solution recalled due to lot RZ1598 exceeded the specification limit at the 14-month timepoint.
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: RZ1598, exp. date 02/2023
- Product
- Sirolimus Oral Solution, 1 mg/mL, 60 mL bottle, Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp.…
- Recalling firm
- Apotex Corp.
- Quantity
- 2353 bottles
- Distribution
- Nationwide in the USA
- Recall date
- May 25, 2022
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)