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Class III: unlikely to cause harmTerminated

Mylan Pharmaceuticals Famotidine Tablets Recall

Famotidine Tablets USP, 20 mg, 100 count bottles, Rx Only, Mylan Pharmaceuticals, Inc

Mylan Pharmaceuticals Inc. · Morgantown, WV

Risk level
Class III
Reported by FDA
Oct 10, 2012
Recall ID
D-1703-2012
Check your lot numberHow we source this data

Summary

Mylan Pharmaceuticals recalled Famotidine Tablets starting Jun 28, 2012. The FDA classified it as Class III (unlikely to cause harm) and published enforcement report D-1703-2012 on Oct 10, 2012. Reason: Impurities/Degradation Products: Out of specification results for Related Compound during routine stability testing. Status: Terminated.

Why it was recalled

Impurities/Degradation Products: Out of specification results for Related Compound during routine stability testing.

Product description

Famotidine Tablets USP, 20 mg, 100 count bottles, Rx Only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A. NDC 0378-3020-01

Lot numbers, UPCs & expiration codes

Lot: 3018952, Exp 08/12

Where it was sold

Nationwide and PR

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-1703-2012
Classification
Class III
Status
Terminated
Recall initiated
Jun 28, 2012
FDA report date
Oct 10, 2012
Quantity
31,867 Bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Mylan Pharmaceuticals Inc.

Original FDA data

Every field from FDA enforcement report D-1703-2012, exactly as published.

Show all FDA fields
City
Morgantown
State
WV
Status
Terminated
Country
United States
Event ID
62911
Address
781 Chestnut Ridge Rd
Code information
Lot: 3018952, Exp 08/12
Postal code
26505-2730
Report date
Oct 10, 2012
Product type
Drugs
Recall number
D-1703-2012
Classification
Class III
Recalling firm
Mylan Pharmaceuticals Inc.
Product quantity
31,867 Bottles
Termination date
Mar 29, 2013
Reason for recall
Impurities/Degradation Products: Out of specification results for Related Compound during routine stability testing.
Voluntary / mandated
Voluntary: Firm initiated
Product description
Famotidine Tablets USP, 20 mg, 100 count bottles, Rx Only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A. NDC 0378-3020-01
Distribution pattern
Nationwide and PR
Recall initiation date
Jun 28, 2012
Initial firm notification
Letter
Center classification date
Sep 28, 2012

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1703-2012, published Oct 10, 2012. 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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