fda
2 records
FDA Drug Recall: Unisom, SleepMinis, Diphenhydramine HCl, Mini-Capsules, 25 mg, 60 Mini-Capsules
2025-04-23
Class II — CGMP Deviations; detection of Nitrosamine Drug Substance-Related Impurities (NDSRI), N-nitroso-desmethyl-diphenhydramine (n-dph), above the FDA Recommended Intake Limit
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FDA Drug Recall: Unisom, SleepMelts, Diphenhydramine HCl tablets, 25 mg, Nighttime Sleep-Aid, 4 x
2025-03-19
Class II — CGMP Deviations: Nitrosamine Drug Substance Related Issue impurity above the daily acceptable intake limit defined by the Food and Drug Administration.
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fda_adverse
1 records
FDA AE Manufacturer: Chattem, Inc.
Drug adverse event reporter — Product: DOCUSATE SODIUM
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