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A&H Focal Inc. Recall: LANG YI HAO CHAONONGSUOPIAN tablets, 500 mg, 8-count bottle, labeli

A&H Focal Inc. Recall: LANG YI HAO CHAONONGSUOPIAN tablets, 500 mg, 8-count bottle, labeli is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: A&H Focal Inc.; Product: LANG YI HAO CHAONONGSUOPIAN tablets, 500 mg, 8-count bottle, labeling is in foreign language; Reason for recall: Marked Wi

Recalling firmA&H Focal Inc.
ProductLANG YI HAO CHAONONGSUOPIAN tablets, 500 mg, 8-count bottle, labeling is in foreign language
Reason for recallMarked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall.
ClassificationClass I (most serious — reasonable probability of serious health consequences or death)
StatusTerminated
DistributionNY and NJ through six retail stores named "Asian Food Markets"
Recall initiated20170307
Recall numberD-0558-2018
Categorydrug
StateNY
CountryUnited States

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