openFDA Drug Enforcement
Report-date coverage
June 20, 2012–July 08, 2026
Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.
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drug · product 1 of 1
Rite Aid brand Maximum Strength Tussin Cough & Cold Mucus Relief CF, (dextromethorphan HBr 10 mg, guaifenesin 200 mg and phenylephrine HCl 5 mg), 4 oz. package size, Distributed by: Rite Aid, Camp Hill, PA --- UPC Code: 0 11822 57307 8.
Presence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was observed in some bottles. If the product is shaken or warmed the white particles goes into the solution.
These labels are deterministic app interpretations, not FDA categories.
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Reason for recall
Presence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was observed in some bottles. If the product is shaken or warmed the white particles goes into the solution.
Code information
Lot # 82507 and 82720.
Distribution pattern
Nationwide in the US: MD, MI, AL, NC, CT, NY, PA, OR, WV.
