Reported Jul 5, 2017 · Terminated
Doxycycline Hyclate USP, active pharmaceutical ingredient, a) 25 g packaged in a 500 cc container (NDC: 58597-8082-4),…
American Pharmaceutical Ingredients LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: American Pharmaceutical Ingredients LLC · 6650 Highland Rd Ste 302 · Waterford, MI · 48327-1665
Is this the product you have?
- 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 1000
- g packaged in 1 gallon container (NDC58597-8082-8). For Prescription Compounding RX Only. Packed under cGMP conditions by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
- Lot codes and dates
- Lot
082815-1EXP 06/04/2019
- Lot
- Amount recalled
- 23.5kg
Where it was sold
- Nationwide
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.
This product could cause temporary or reversible health problems — stop using it.
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