drugs LOW RISK Updated 2022-05-25

Apotex Corp. recalls Sirolimus Oral Solution, 1 mg/mL, 60 mL bottle, Rx Only, Man

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Recalled 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. Weston, Florida 33326, NDC 60505-6197-2

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Hazard / Issue

Failed Dissolution Specifications: Sirolimus Oral Solution recalled due to lot RZ1598 exceeded the specification limit at the 14-month timepoint.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot: RZ1598, exp. date 02/2023

✅ What Should You Do?

  1. 1Stop taking this medication and contact your doctor or pharmacist immediately.
  2. 2Do NOT flush medications down the drain — use an FDA-approved drug take-back program.
  3. 3Check the lot number on your bottle or packaging against the recalled lots listed above.
  4. 4Report adverse events to FDA MedWatch or call 1-800-FDA-1088.

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