Recalls / Class II
Class IID-0506-2018
Product
Lidocaine HCl USP for prescription compounding, packaged in a) 100g (NDC 58597-8020-6); b) 500g (NDC 58597-8020-7); c) 1000g (NDC 58597-8020-8) RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
- Affected lot / code info
- Lot #: a) 021115-1, Exp. 01/15/2020; 080415-1, Exp. 03/22/2020; b) 020116-2, Exp. 12/13/2020; 021115-1, Exp. 01/15/2020; 080415-1, Exp. 03/22/2020; c) 020116-1, 020116-2, Exp. 12/13/2020; 021115-1, exp. 01/15/2020; 080415-1, Exp. 03/22/2020; 082416-1, 082416-2 Exp. 01/31/2021.
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
- 166000 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-0506-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.