Class II · Moderate risk
Clindamycin Injection USP in 5% Dextrose
CGMP Deviations
Clindamycin Phosphate
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Defective Container: Out of specification for weight due to a slow leakage at the 12-month stability timepoint.
Cause type: Packaging defect
Failed child-resistant closures, leaks, cracked containers, or a defective delivery device. Packaging failures risk accidental exposure (especially to children) or product contamination. All packaging defect recalls.
What was recalled
Clindamycin Phosphate, Topical Solution USP, 1%, 60 mL, Rx Only, Manufactured for and Distributed by: Marlex Pharmaceuticals, Inc., New Castle, DE 19720, NDC 10135-0691-61
Affected NDC
10135-0691-61
Compare with the code on your package — it is the most precise check available.
Drug: Clindamycin Category: Antibiotic
- Recalling firm
- Contract Pharmaceuticals Limited Canada
- NDC code
- 10135-0691-61
- Origin
- Canada
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0364-2024 · 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.
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 recalls by Contract Pharmaceuticals Limited Canada
All 2024 recalls
Class III · Low risk
Clindamycin Phosphate Topical Solution USP
Defective Container: Out of specification for weight due to a slow leakage at the 12-month stability timepoint.
Class III · Low risk
Clindamycin Phosphate Topical Solution USP
Defective Container: slow leakage under the cap
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