Why it was recalled
Failed Impurities/Degradation Specifications
Product description
Sirolimus Tablets 1 mg, 30 Tablets (5 blister cards x 6 unit doses), Rx only, Packaged and Distributed by: American Health Packaging Columbus, OH 43217, NDC 68084-915-25
Lot numbers, UPCs & expiration codes
Lot #: 1000789, Exp. Date 10/31/2022
Where it was sold
Nationwide within the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0813-2021
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- May 12, 2021
- FDA report date
- Sep 29, 2021
- Quantity
- 290 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- American Health Packaging
Original FDA data
Every field from FDA enforcement report D-0813-2021, exactly as published.
Show all FDA fields
- City
- Columbus
- State
- OH
- Status
- Terminated
- Country
- United States
- Event ID
- 88650
- Address
- 2550 John Glenn Ave Ste A
- Code information
- Lot #: 1000789, Exp. Date 10/31/2022
- Postal code
- 43217-1188
- Report date
- Sep 29, 2021
- Product type
- Drugs
- Recall number
- D-0813-2021
- Classification
- Class III
- Recalling firm
- American Health Packaging
- Product quantity
- 290 cartons
- Termination date
- Aug 25, 2022
- Reason for recall
- Failed Impurities/Degradation Specifications
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Sirolimus Tablets 1 mg, 30 Tablets (5 blister cards x 6 unit doses), Rx only, Packaged and Distributed by: American Health Packaging Columbus, OH 43217, NDC 68084-915-25
- Distribution pattern
- Nationwide within the USA
- Recall initiation date
- May 12, 2021
- Initial firm notification
- Letter
- Center classification date
- Sep 20, 2021