Recalls / Class II
Class IID-0927-2017
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
- Affected lot / code info
- Lot: 082815-1, EXP 06/04/2019
Why it was recalled
Labeling: Not Elsewhere Classified. Manufacturer and product were discovered to be on FDA Import Alert 66-66 for misbranding of active pharmaceutical ingredient.
Recalling firm
- Firm
- American Pharmaceutical Ingredients LLC
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 6650 Highland Rd Ste 302, N/A, Waterford, Michigan 48327-1665
Distribution
- Quantity
- 23.5kg
- Distribution pattern
- Nationwide in the US
Timeline
- Recall initiated
- 2017-06-01
- FDA classified
- 2017-06-29
- Posted by FDA
- 2017-07-05
- Terminated
- 2018-05-31
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0927-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.