Drug product
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
D-0927-2017
Product summary
- Event
- Event 77525
- Status
- Terminated
- Classification
- Class II
- Quantity
- 23.5kg
- Official record key
drug-enforcement:D-0927-2017
Official wording
Reason: Labeling: Not Elsewhere Classified. Manufacturer and product were discovered to be on FDA Import Alert 66-66 for misbranding of active pharmaceutical ingredient.
Code information: Lot: 082815-1, EXP 06/04/2019
Distribution pattern: Nationwide in the US
Derived failure modes
-
Labeling or packaging
misbranding