Clindamycin Injection USP in 5% Dextrose
CGMP Deviations
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
CGMP Deviations
Cause type: cGMP deviation
Departures from current Good Manufacturing Practice found in production or during FDA inspection. A broad quality-system cause: the batch was made under conditions that fall short of FDA manufacturing standards. All cgmp deviation recalls.
Clindamycin Injection USP in 5% Dextrose, 900 mg/50 mL (18 mg/mL), in GALAXY 50 mL Single Dose Container, Rx only, Sterile Nonpyrogenic, Manufactured by: Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 43066-995-24.
Compare with the code on your package — it is the most precise check available.
Drug: Clindamycin Category: Antibiotic
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 |
|---|---|---|---|---|
| Clindamycin phosphate NDC 43066-0995 |
900 mg/50mL | Injection, Solution Intravenous |
Baxter Healthcare Corporation | Rx |
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall.
CGMP Deviations
CGMP Deviations
CGMP Deviations
CGMP Deviations
Presence of Foreign Substance: presence of particles and white flakes in the reconstituted bottles.
Presence of Particulate Matter: particulate matter identified as stainless steel particles in the solution.
Presence of particulate matter: Particulates identified as fiberglass
CGMP Deviations
CGMP Deviations
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