Why it was recalled
Microbial Contamination of Non-Sterile Product; small number of tubes may include the presence of mold on the cap
Product description
Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5%, 45 g tubes, Rx Only, Manufactured by Perrigo, Yeruham, Israel, Distributed by Perrigo, Allegan, MI --- NDC 45802-736-84, UPC 345802736840
Lot numbers, UPCs & expiration codes
080806 (exp 12/16) 080844 ( exp 12/16) 080963 (exp 12/16) 080999 ( exp 12/16) 0841 09 ( exp 03/17 084197 ( exp 03/17) 091 090 ( exp 1 0/17) 092319 (exp 11/17) 092399 ( exp 12/17) 092440 ( exp 12/17)
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-0434-2017
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Dec 28, 2016
- FDA report date
- Jan 25, 2017
- Quantity
- 162,534 tubes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- L. Perrigo Company
Original FDA data
Every field from FDA enforcement report D-0434-2017, exactly as published.
Show all FDA fields
- City
- Allegan
- State
- MI
- Status
- Terminated
- Country
- United States
- Event ID
- 76061
- Address
- 515 Eastern Ave
- Code information
- 080806 (exp 12/16) 080844 ( exp 12/16) 080963 (exp 12/16) 080999 ( exp 12/16) 0841 09 ( exp 03/17 084197 ( exp 03/17) 091 090 ( exp 1 0/17) 092319 (exp 11/17) 092399 ( exp 12/17) 092440 ( exp 12/17)
- Postal code
- 49010-9070
- Report date
- Jan 25, 2017
- Product type
- Drugs
- Recall number
- D-0434-2017
- Classification
- Class II
- Recalling firm
- L. Perrigo Company
- Product quantity
- 162,534 tubes
- Termination date
- Aug 22, 2017
- Reason for recall
- Microbial Contamination of Non-Sterile Product; small number of tubes may include the presence of mold on the cap
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5%, 45 g tubes, Rx Only, Manufactured by Perrigo, Yeruham, Israel, Distributed by Perrigo, Allegan, MI --- NDC 45802-736-84, UPC 345802736840
- Distribution pattern
- Nationwide
- Recall initiation date
- Dec 28, 2016
- Initial firm notification
- Letter
- Center classification date
- Jan 17, 2017