Why it was recalled
Failed Impurities/Degradation Specifications: The API for these products had an out of specification result for an organic impurity.
Product description
Salicylic Acid Cream, 6%, 400g bottle, Rx Only, Manufactured By Perrigo Yeruham, Israel 80500, Distributed By Perrigo Allegan, MI 49010, NDC 45802-806-01, UPC 3 45802-806-01 7.
Lot numbers, UPCs & expiration codes
Lot #: 098840, 098779, Exp.06/18.
Where it was sold
Nationwide within 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-0504-2017
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Feb 13, 2017
- FDA report date
- Mar 8, 2017
- Quantity
- 10,656 units total for both products
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- L. Perrigo Company
Original FDA data
Every field from FDA enforcement report D-0504-2017, exactly as published.
Show all FDA fields
- City
- Allegan
- State
- MI
- Status
- Terminated
- Country
- United States
- Event ID
- 76443
- Address
- 515 Eastern Ave
- Code information
- Lot #: 098840, 098779, Exp.06/18.
- Postal code
- 49010-9070
- Report date
- Mar 8, 2017
- Product type
- Drugs
- Recall number
- D-0504-2017
- Classification
- Class III
- Recalling firm
- L. Perrigo Company
- Product quantity
- 10,656 units total for both products
- Termination date
- Sep 26, 2017
- Reason for recall
- Failed Impurities/Degradation Specifications: The API for these products had an out of specification result for an organic impurity.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Salicylic Acid Cream, 6%, 400g bottle, Rx Only, Manufactured By Perrigo Yeruham, Israel 80500, Distributed By Perrigo Allegan, MI 49010, NDC 45802-806-01, UPC 3 45802-806-01 7.
- Distribution pattern
- Nationwide within United States
- Recall initiation date
- Feb 13, 2017
- Initial firm notification
- Letter
- Center classification date
- Mar 1, 2017