FDA-Drug2018-02-28Class II
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
American Pharmaceutical Ingredients LLC
Hazard
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Sold states
Nationwide within USA.
Affected count
166000 g
Manufactured in
6650 Highland Rd Ste 302, N/A, Waterford, MI, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0506-2018Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief