FDA (Drugs) recall action 85726
The FDA (Drugs) publishes a recall like this one as 4 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 4 pages.
CGMP Deviations: due to the loss of product manufacturing records and retain product samples, there is no assurance that the product will remain within specification through the labeled expiration date.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Wuhan Bingbing Pharmaceutical is recalling Mencaine patches because manufacturing records and samples were lost, preventing verification that the product remains within specification through expiration.
Wuhan Bingbing Pharmaceutical is recalling LidoPatch pain relief patches because missing manufacturing records prevent verification that the product remains within specification through its expiration date.
Wuhan Bingbing Pharmaceutical is recalling LidoPro patches because manufacturing records and samples were lost, preventing verification of product stability.
CVS Pharmacy is recalling Maximum Strength Lidocaine Cold & Hot Patches because manufacturing records and samples were lost, meaning the product may not remain within specification through its expiration date.