Class II
Terminated
Doxycycline Hyclate USP, active pharmaceutical ingredient, a) 25 g packaged in a 500 cc container (NDC: 58597-8082-4), b) 100 g packaged in 16 oz container (NDC: 58597-8082-6), c) 500 g packaged in a 2500 cc container (NDC: 58597-8082-7) and a 1,000 g packaged in 1 gallon container (NDC: 58597-8082-8). For Prescription Compounding RX Only. Packed under cGMP conditions by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
- Recall Initiated
- June 1, 2017
- Posted
- July 5, 2017
- Recall Number
- D-0927-2017
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 23.5kg
- Firm Location
- Waterford, MI, United States
Reason for Recall
Labeling: Not Elsewhere Classified. Manufacturer and product were discovered to be on FDA Import Alert 66-66 for misbranding of active pharmaceutical ingredient.
Distribution
Nationwide in the US
Lot / Code Info
Lot: 082815-1, EXP 06/04/2019
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