FDA recall, , Low risk
Sun Pharmaceutical Clindamycin Phosphate Topical Solution
Failed Impurities/Degradation: Out of Specification results for Total Impurities and for Assay.
Summary by Recall Canary from the FDA notice
What happened
SUN PHARMACEUTICAL INDUSTRIES INC, of Princeton, New Jersey, recalled Clindamycin Phosphate USP, 1% (10 mg/mL), Topical Solution, 60 mL per applicator bottle, Rx only, because of Failed Impurities/Degradation: Out of Specification results for Total Impurities and for Assay. The product was distributed nationwide in the USA.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is yours affected?
Match the NDC and lot code listed under your product.
An NDC (National Drug Code) is usually printed on the drug's label.
Clindamycin Phosphate USP, 1% (10 mg/mL), Topical Solution
- NDC
- 51672-4081-4
- Lot code
- AD30154
- AD31143
- AD31145
Recall details
- Company began the recall
- Sold in
Nationwide in the USA.
- Company
- SUN PHARMACEUTICAL INDUSTRIES INCPrinceton, New Jersey
- Hazard
- Drug impurity
- Risk
Low risk
Taking it is unlikely to cause health problems.
FDA Class III recall · How risk is rated
- Event ID
- 98062
- Recall number
- D-0257-2026
All recalls from SUN PHARMACEUTICAL INDUSTRIES INC
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
