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.
Product description
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
Lot numbers, UPCs & expiration codes
Lot: 082815-1, EXP 06/04/2019
Where it was sold
Nationwide in the US
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0927-2017
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jun 1, 2017
- FDA report date
- Jul 5, 2017
- Quantity
- 23.5kg
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- American Pharmaceutical Ingredients LLC
Original FDA data
Every field from FDA enforcement report D-0927-2017, exactly as published.
Show all FDA fields
- City
- Waterford
- State
- MI
- Status
- Terminated
- Country
- United States
- Event ID
- 77525
- Address
- 6650 Highland Rd Ste 302
- Code information
- Lot: 082815-1, EXP 06/04/2019
- Postal code
- 48327-1665
- Report date
- Jul 5, 2017
- Product type
- Drugs
- Recall number
- D-0927-2017
- Classification
- Class II
- Recalling firm
- American Pharmaceutical Ingredients LLC
- Product quantity
- 23.5kg
- Termination date
- May 31, 2018
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide in the US
- Recall initiation date
- Jun 1, 2017
- Initial firm notification
- Telephone
- Center classification date
- Jun 29, 2017