Recalls / Class II
Class IID-0524-2018
Product
Tadalafil USP (Monohydrate) for prescription compounding, packaged in a) 5g (NDC 58597-8538-2); b) 25g (NDC 58597-8538-4); c)100g (NDC 58597-8538-6); d) 500g (NDC 58597-8538-7); d) 1000g (NDC 58597-8538-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
- Affected lot / code info
- Lot #: a) 020717-3, Exp. 12/31/2021; b) 020717-2 020717-4, 020717-5 Exp. 12/31/2021; 092816-2, 092816-3, Exp. 07/31/2021; 121015-4, 121015-5, 121015-6, Exp.10/31/2020; c) 020717-1, 020717-4, 020717-5, Exp. 12/31/2021; 092816-1, Exp. 07/31/2021; 092816-2, Exp. 07/31/2021; 121015-1,121015-3, Exp. 10/31/2020; d) 020717-1, 020717-2, Exp. 12/31/2021; 092816-1, Exp. 07/31/2021; 121015-2, Exp. 10/31/2020; e) 020717-1,020717-2 Exp. 12/31/2021.
Why it was recalled
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Recalling firm
- Firm
- American Pharmaceutical Ingredients LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 6650 Highland Rd Ste 302, N/A, Waterford, Michigan 48327-1665
Distribution
- Quantity
- 90000 g
- Distribution pattern
- Nationwide within USA.
Timeline
- Recall initiated
- 2018-02-09
- FDA classified
- 2018-02-22
- Posted by FDA
- 2018-02-28
- Terminated
- 2019-12-02
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0524-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.