Why it was recalled
CGMP Deviations
Product description
Torsemide Tablets, 20 mg 100-count bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada, M9W, 6Y3, Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-0234-01
Lot numbers, UPCs & expiration codes
Lot #: KT5981, KT5982, KT5983; Exp. Date 01/17.
Where it was sold
United States
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-0244-2017
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Dec 14, 2016
- FDA report date
- Jan 11, 2017
- Quantity
- 35,819 bottles (358,190,000 tablets)
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Apotex Corp.
Original FDA data
Every field from FDA enforcement report D-0244-2017, exactly as published.
Show all FDA fields
- City
- Weston
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 75964
- Address
- 2400 N Commerce Pkwy Ste 400
- Code information
- Lot #: KT5981, KT5982, KT5983; Exp. Date 01/17.
- Postal code
- 33326-3253
- Report date
- Jan 11, 2017
- Product type
- Drugs
- Recall number
- D-0244-2017
- Classification
- Class II
- Recalling firm
- Apotex Corp.
- Product quantity
- 35,819 bottles (358,190,000 tablets)
- Termination date
- Jun 15, 2022
- Reason for recall
- CGMP Deviations
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Torsemide Tablets, 20 mg 100-count bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada, M9W, 6Y3, Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-0234-01
- Distribution pattern
- United States
- Recall initiation date
- Dec 14, 2016
- Initial firm notification
- Letter
- Center classification date
- Jan 2, 2017