Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
PROMETHAZINE PLAIN ORAL SOLUTION 6.25MG/5ML 473ML; ; RX; SOLUTION (USUALLY NOT OTIC, OPTH, NASAL DROPS), Rx Only, NDC 0211-0927-16
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.
Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Reason cGMP deviations: Temperature abuse
Reason CGMP Deviations
Reason CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.
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