FDA Drug Class II — Moderate

Doxycycline Hyclate Tablets, USP 100 mg*, 500-count bottle, Rx Only, Distributed by: Acella Pharmaceuticals, LLC, Alpharetta, GA 30005, NDC 42192-501-05.

Hazard

Failed dissolution specifications: Stability testing found that the lot did not meet dissolution specifications.

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Products

Doxycycline Hyclate Tablets, USP 100 mg*, 500-count bottle, Rx Only, Distributed by: Acella Pharmaceuticals, LLC, Alpharetta, GA 30005, NDC 42192-501-05.
Brand
Acella Pharmaceuticals, LLC
UPC
Lot #: P24ZLK1, Exp 5/31/2027

Units Affected

4,680 500-count bottles

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