Class II · Moderate risk Ongoing
Promethazine HCl Oral Solution
Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Promethazine HCl Topical Ointment
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations
What was recalled
Promethazine HCl Topical Ointment, 2.5% (25 mg/mL), 1.2 mL per syringe, Single Dose Syreinge for Topical Use Only, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1341-01
- Recalling firm
- Edge Pharma, LLC
- NDC code
- 05446-1341-01
- Origin
- VT, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0446-2022
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 Promethazine recalls
See all
Class II · Moderate risk Ongoing
Promethazine HCl & Codeine Phosphate Oral Solution
Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk Terminated
Promethazine HCl Tablets
Reason cGMP deviations: Temperature abuse
Class II · Moderate risk Completed
Promethazine With Codeine Oral Solution
Reason CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.
Class II · Moderate risk Completed
Promethazine Syrup Plain
Reason CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.
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