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Class III: unlikely to cause harmTerminated

Valeant Pharmaceuticals North Am Acanya Recall

Acanya (Clindamycin Phosphate and Benzoyl Peroxide) Gel 1

Valeant Pharmaceuticals North Am · Bridgewater, NJ

Risk level
Class III
Reported by FDA
Dec 4, 2013
Recall ID
D-020-2014
Check your lot numberHow we source this data

Summary

Valeant Pharmaceuticals North Am recalled Acanya starting Sep 20, 2013. The FDA classified it as Class III (unlikely to cause harm) and published enforcement report D-020-2014 on Dec 4, 2013. Reason: Labeling: Incorrect or Missing Lot and/or Exp Date: This recall is being carried out due to an incorrect expiration date assigned to a lot of physicians samples. Status: Terminated.

Why it was recalled

Labeling: Incorrect or Missing Lot and/or Exp Date: This recall is being carried out due to an incorrect expiration date assigned to a lot of physicians samples.

Product description

Acanya (Clindamycin Phosphate and Benzoyl Peroxide) Gel 1.2% and 2.5%, Net Wt. 3.5 g, Rx Only, Sample - not for sale, CORIA Laboratories, a division of Valeant Pharmaceuticals LLC, Bridgewater, NJ 08807 --- NDC 13548-132-03

Lot numbers, UPCs & expiration codes

Lot AC27198F6

Where it was sold

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-020-2014
Classification
Class III
Status
Terminated
Recall initiated
Sep 20, 2013
FDA report date
Dec 4, 2013
Quantity
45,000 tubes
Recall type
Voluntary: Firm initiated
Recalling firm
Valeant Pharmaceuticals North Am

Original FDA data

Every field from FDA enforcement report D-020-2014, exactly as published.

Show all FDA fields
City
Bridgewater
State
NJ
Status
Terminated
Country
United States
Event ID
66356
Address
700 Us Highway
Code information
Lot AC27198F6
Postal code
08807
Report date
Dec 4, 2013
Product type
Drugs
Recall number
D-020-2014
Classification
Class III
Recalling firm
Valeant Pharmaceuticals North Am
Product quantity
45,000 tubes
Termination date
Mar 24, 2014
Reason for recall
Labeling: Incorrect or Missing Lot and/or Exp Date: This recall is being carried out due to an incorrect expiration date assigned to a lot of physicians samples.
Voluntary / mandated
Voluntary: Firm initiated
Product description
Acanya (Clindamycin Phosphate and Benzoyl Peroxide) Gel 1.2% and 2.5%, Net Wt. 3.5 g, Rx Only, Sample - not for sale, CORIA Laboratories, a division of Valeant Pharmaceuticals LLC, Bridgewater, NJ 08807 --- NDC 13548-132-03
Distribution pattern
United States
Recall initiation date
Sep 20, 2013
Initial firm notification
Letter
Center classification date
Nov 26, 2013

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-020-2014, published Dec 4, 2013. 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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