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Class II: temporary or reversible health riskTerminated

Teva Pharmaceuticals Terazosin Hydrochloride Capsules Recall

Terazosin Hydrochloride Capsules,10 mg, 100-count bottle, Rx only, Manufactured for Tev…

Teva Pharmaceuticals USA, Inc. · Sellersville, PA

Risk level
Class II
Reported by FDA
Aug 14, 2013
Recall ID
D-842-2013
Check your lot numberHow we source this data

Summary

Teva Pharmaceuticals recalled Terazosin Hydrochloride Capsules starting Jul 23, 2013. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-842-2013 on Aug 14, 2013. Reason: Labeling -label error on declared strength: unopened, sealed bottle of Terazosin Hydrochloride (HCl) 10mg Capsules contained Terazosin HCl 5 mg Capsules. Status: Terminated.

Why it was recalled

Labeling -label error on declared strength: unopened, sealed bottle of Terazosin Hydrochloride (HCl) 10mg Capsules contained Terazosin HCl 5 mg Capsules

Product description

Terazosin Hydrochloride Capsules,10 mg, 100-count bottle, Rx only, Manufactured for Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0093-4339-01

Lot numbers, UPCs & expiration codes

Lot # N07321, Exp 6/14

Where it was sold

Nationwide and Puerto Rico

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-842-2013
Classification
Class II
Status
Terminated
Recall initiated
Jul 23, 2013
FDA report date
Aug 14, 2013
Quantity
6267 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Teva Pharmaceuticals USA, Inc.

Original FDA data

Every field from FDA enforcement report D-842-2013, exactly as published.

Show all FDA fields
City
Sellersville
State
PA
Status
Terminated
Country
United States
Event ID
65826
Address
650 Cathill Rd
Code information
Lot # N07321, Exp 6/14
Postal code
18960-1512
Report date
Aug 14, 2013
Product type
Drugs
Recall number
D-842-2013
Classification
Class II
Recalling firm
Teva Pharmaceuticals USA, Inc.
Product quantity
6267 bottles
Termination date
Aug 27, 2014
Reason for recall
Labeling -label error on declared strength: unopened, sealed bottle of Terazosin Hydrochloride (HCl) 10mg Capsules contained Terazosin HCl 5 mg Capsules
Voluntary / mandated
Voluntary: Firm initiated
Product description
Terazosin Hydrochloride Capsules,10 mg, 100-count bottle, Rx only, Manufactured for Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0093-4339-01
Distribution pattern
Nationwide and Puerto Rico
Recall initiation date
Jul 23, 2013
Initial firm notification
Letter
Center classification date
Aug 6, 2013

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-842-2013, published Aug 14, 2013. 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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