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Class II: temporary or reversible health riskTerminated

Apotex Torsemide Tablets Recall

Torsemide Tablets, 5 mg 100-count bottle, Rx only ,Manufactured by: Apotex Inc

Apotex Corp. · Weston, FL

Risk level
Class II
Reported by FDA
Jan 11, 2017
Recall ID
D-0245-2017
Check your lot numberHow we source this data

Summary

Apotex recalled Torsemide Tablets starting Dec 14, 2016. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0245-2017 on Jan 11, 2017. Reason: CGMP Deviations. Status: Terminated.

Why it was recalled

CGMP Deviations

Product description

Torsemide Tablets, 5 mg 100-count bottle, Rx only ,Manufactured by: Apotex Inc., Toronto, Ontario, Canada, M9W, 6Y3, Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-0232-01

Lot numbers, UPCs & expiration codes

Lot #: KW8378; Exp. Date 05/17.

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-0245-2017
Classification
Class II
Status
Terminated
Recall initiated
Dec 14, 2016
FDA report date
Jan 11, 2017
Quantity
13,179 bottles (1,317,900 tablets)
Recall type
Voluntary: Firm initiated
Recalling firm
Apotex Corp.

Original FDA data

Every field from FDA enforcement report D-0245-2017, 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 #: KW8378; Exp. Date 05/17.
Postal code
33326-3253
Report date
Jan 11, 2017
Product type
Drugs
Recall number
D-0245-2017
Classification
Class II
Recalling firm
Apotex Corp.
Product quantity
13,179 bottles (1,317,900 tablets)
Termination date
Jun 15, 2022
Reason for recall
CGMP Deviations
Voluntary / mandated
Voluntary: Firm initiated
Product description
Torsemide Tablets, 5 mg 100-count bottle, Rx only ,Manufactured by: Apotex Inc., Toronto, Ontario, Canada, M9W, 6Y3, Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-0232-01
Distribution pattern
United States
Recall initiation date
Dec 14, 2016
Initial firm notification
Letter
Center classification date
Jan 2, 2017

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0245-2017, published Jan 11, 2017. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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