Class II · Moderate risk
Clindamycin Injection USP in 5% Dextrose
CGMP Deviations
Acanya (Clindamycin Phosphate and Benzoyl Peroxide)
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
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.
Cause type: Labeling / mix-up
Wrong label, wrong strength, mixed-up products, or packaging errors. One of the most dangerous causes - you can end up taking the wrong drug or the wrong dose. All labeling / mix-up recalls.
What was recalled
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
Affected NDC
13548-0132-03
Compare with the code on your package — it is the most precise check available.
Drug: Clindamycin Category: Antibiotic
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Acanya Clindamycin Phosphate and Benzoyl Peroxide NDC 13548-0132 |
CLINDAMYCIN PHOSPHATE 10 mg/g; BENZOYL PEROXIDE 25 mg/g | Gel Topical |
Bausch Health US, LLC | Rx |
- Recalling firm
- Valeant Pharmaceuticals North Am
- NDC code
- 13548-132-03
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-020-2014 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Clindamycin recalls
See all
Class II · Moderate risk
Clindamycin Injection USP in 5% Dextrose
CGMP Deviations
Class II · Moderate risk
Clindamycin Phosphate in 0.9% Sodium Chloride Injection
CGMP Deviations
Class II · Moderate risk
Clindamycin Injection USP in 5% Dextrose
CGMP Deviations
Class II · Moderate risk
Clindamycin Injection USP in 5% Dextrose
CGMP Deviations
Other labeling / mix-up recalls from 2013
All labeling / mix-up recalls
Class II · Moderate risk
Trelstar (triptorelin pamoate)
Labeling: Label Error On Declared Strength: Trelstar 11.25 mg labeled carton/kit contained a vial labeled as 3.75 mg instead of a vial being labeled as 11.25mg.
Class II · Moderate risk
0.45% Sodium Chloride Injection USP
Labeling: Wrong Bar Code; Bar code scans as 0.15% Potassium Chloride in 0.9% Sodium Chloride (20 mEq K/liter).
Class III · Low risk
Paclitaxel Injection
Labeling: Incorrect or Missing Package Insert- Missing text on the product insert in the "Clinical Studies" and "Specific Adverse Events" sections.
Class II · Moderate risk
Carbon Dioxide
Labeling: Not Elsewhere Classified; Due to an error in the manufacturing procedure, a cylinder in liquid withdrawal service was not marked Syphon Tube indicating liquid withdrawal and shipped as a gas withdrawal cylinder.
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