Class II · Moderate risk Ongoing
Clindamycin Palmitate Hydrochloride for Oral Solution
Reason Presence of Foreign Substance: presence of particles and white flakes in the reconstituted bottles.
Cleocin Phosphate
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Presence of Particulate Matter: Firm is recalling a small number of vials with very small reflective flakes consistent with delamination of the glass vial.
What was recalled
Cleocin Phosphate (clindamycin Injection), USP, a) 600 mg/4mL (150 mg/mL) ADD-Vantage Vial, b) 900 mg/6mL (150 mg/mL) ADD-Vantage Vial, Rx Only, For Intravenous Use Only, Use Only with the ADD-Vantage diluent container, Distributed by Pharmacia & Upjohn Co, Division of Pfizer Inc, NY, NY 10017, NDC a) 0009-3124-03 and b) 0009-3447-03
- Recalling firm
- Pharmacia & Upjohn LLC
- Origin
- MI, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-609-2013
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Clindamycin recalls
See all
Class III · Low risk Ongoing
Clindamycin Phosphate USP
Reason Failed Impurities/Degradation: Out of Specification results for Total Impurities and for Assay.
Class II · Moderate risk Ongoing
Clindamycin HCl Capsule
Reason CGMP Deviations - products manufactured in a shared facility with Ezetimibe tablets.
Class II · Moderate risk Ongoing
Clindamycin Hydrochloride Capsules
Reason cGMP Deviations
Class II · Moderate risk Ongoing
Clindamycin HCl
Reason CGMP Deviations
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