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Class III: unlikely to cause harmTerminated

Perrigo Israel Pharmaceuticals Mometasone Furoate Ointment Recall

Mometasone Furoate Ointment USP, 0

Perrigo Israel Pharmaceuticals · Yeruham, N/A

Risk level
Class III
Reported by FDA
Aug 12, 2015
Recall ID
D-1286-2015
Check your lot numberHow we source this data

Summary

Perrigo Israel Pharmaceuticals recalled Mometasone Furoate Ointment starting Jul 13, 2015. The FDA classified it as Class III (unlikely to cause harm) and published enforcement report D-1286-2015 on Aug 12, 2015. Reason: Subpotent drug. Status: Terminated.

Why it was recalled

Subpotent drug

Product description

Mometasone Furoate Ointment USP, 0.1%, 15 g tubes, Rx Only, Manufactured by Perrigo, Yeruham 80500, Israel, Distributed by Perrigo, Allegan, MI 49010, NDC 45802-0119-37

Lot numbers, UPCs & expiration codes

Lot # 063630, Exp 04/16; 069793, Exp 11/16; 071745, Exp 02/17; 076150, Exp 07/17; 081317, Exp 12/17

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-1286-2015
Classification
Class III
Status
Terminated
Recall initiated
Jul 13, 2015
FDA report date
Aug 12, 2015
Quantity
158,268 tubes
Recall type
Voluntary: Firm initiated
Recalling firm
Perrigo Israel Pharmaceuticals

Original FDA data

Every field from FDA enforcement report D-1286-2015, exactly as published.

Show all FDA fields
City
Yeruham
Status
Terminated
Country
Israel
Event ID
71765
Address
1 Zvi Bornstein Rd
Code information
Lot # 063630, Exp 04/16; 069793, Exp 11/16; 071745, Exp 02/17; 076150, Exp 07/17; 081317, Exp 12/17
Report date
Aug 12, 2015
Product type
Drugs
Recall number
D-1286-2015
Classification
Class III
Recalling firm
Perrigo Israel Pharmaceuticals
Product quantity
158,268 tubes
Termination date
Feb 11, 2016
Reason for recall
Subpotent drug
Voluntary / mandated
Voluntary: Firm initiated
Product description
Mometasone Furoate Ointment USP, 0.1%, 15 g tubes, Rx Only, Manufactured by Perrigo, Yeruham 80500, Israel, Distributed by Perrigo, Allegan, MI 49010, NDC 45802-0119-37
Distribution pattern
Nationwide and Puerto Rico
Recall initiation date
Jul 13, 2015
Initial firm notification
Letter
Center classification date
Aug 5, 2015

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1286-2015, published Aug 12, 2015. 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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