Recalls / Class II
Class IID-0516-2018
Product
Phentolamine Mesylate USP for prescription compounding, packaged in a) 1g (NDC 58597-8077-3); b) 5g (NDC 58597-8077-4); c) 500g (NDC 58597-8077-7), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
- Affected lot / code info
- Lot #: a) 080315-1, Exp. 04/05/2018; b) 080315-1, Exp. 04/05/2018, c) 080315-1, Exp. 04/05/2018.
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
- 6000 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-0516-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.