Why it was recalled
Failed Degradation/Impurities Specifications: Out of specification related substance results during stability testing.
Product description
Ciclopirox shampoo 1%,120 mL bottle, Rx only, Manufactured By Perrigo Bronx, NY 10457 Distributed by Perrigo Allegan, MI 49010, 45802-401-09
Lot numbers, UPCs & expiration codes
Lot #: 7DT0280, 7ET0565, Exp. 02/19
Where it was sold
Nationwide within the 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-0512-2019
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Feb 13, 2019
- FDA report date
- Feb 27, 2019
- Quantity
- 12252 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Perrigo New York, Inc.
Original FDA data
Every field from FDA enforcement report D-0512-2019, exactly as published.
Show all FDA fields
- City
- Bronx
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 82127
- Address
- 1700 Bathgate Ave
- Code information
- Lot #: 7DT0280, 7ET0565, Exp. 02/19
- Postal code
- 10457-7512
- Report date
- Feb 27, 2019
- Product type
- Drugs
- Recall number
- D-0512-2019
- Classification
- Class III
- Recalling firm
- Perrigo New York, Inc.
- Product quantity
- 12252 bottles
- Termination date
- Sep 8, 2021
- Reason for recall
- Failed Degradation/Impurities Specifications: Out of specification related substance results during stability testing.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Ciclopirox shampoo 1%,120 mL bottle, Rx only, Manufactured By Perrigo Bronx, NY 10457 Distributed by Perrigo Allegan, MI 49010, 45802-401-09
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Feb 13, 2019
- Initial firm notification
- Letter
- Center classification date
- Feb 20, 2019