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Class III: unlikely to cause harmTerminated

Teva Pharmaceuticals Apri Recall

Apri (desogestrel and ethinyl estradiol tablets USP), 0

Teva Pharmaceuticals USA · North Wales, PA

Risk level
Class III
Reported by FDA
Jul 23, 2014
Recall ID
D-1436-2014
Check your lot numberHow we source this data

Summary

Teva Pharmaceuticals recalled Apri starting Jun 17, 2014. The FDA classified it as Class III (unlikely to cause harm) and published enforcement report D-1436-2014 on Jul 23, 2014. Reason: Failed Impurities/Degradation Specifications: out of specification impurity test results. Status: Terminated.

Why it was recalled

Failed Impurities/Degradation Specifications: out of specification impurity test results.

Product description

Apri (desogestrel and ethinyl estradiol tablets USP), 0.15 mg/0.03 mg, 6 Cyclic dispensers X 28 tablets, Rx only, Teva Pharmaceuticals, Sellersville, PA. NDC 0555-9043-58

Lot numbers, UPCs & expiration codes

Lot 3805324A Exp. 11/14

Where it was sold

Nationwide

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-1436-2014
Classification
Class III
Status
Terminated
Recall initiated
Jun 17, 2014
FDA report date
Jul 23, 2014
Quantity
1104 blister packs
Recall type
Voluntary: Firm initiated
Recalling firm
Teva Pharmaceuticals USA

Original FDA data

Every field from FDA enforcement report D-1436-2014, exactly as published.

Show all FDA fields
City
North Wales
State
PA
Status
Terminated
Country
United States
Event ID
68610
Address
1090 Horsham Rd
Code information
Lot 3805324A Exp. 11/14
Postal code
19454-1505
Report date
Jul 23, 2014
Product type
Drugs
Recall number
D-1436-2014
Classification
Class III
Recalling firm
Teva Pharmaceuticals USA
Product quantity
1104 blister packs
Termination date
Mar 9, 2015
Reason for recall
Failed Impurities/Degradation Specifications: out of specification impurity test results.
Voluntary / mandated
Voluntary: Firm initiated
Product description
Apri (desogestrel and ethinyl estradiol tablets USP), 0.15 mg/0.03 mg, 6 Cyclic dispensers X 28 tablets, Rx only, Teva Pharmaceuticals, Sellersville, PA. NDC 0555-9043-58
Distribution pattern
Nationwide
Recall initiation date
Jun 17, 2014
Initial firm notification
Letter
Center classification date
Jul 17, 2014

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1436-2014, published Jul 23, 2014. 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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