Drug product
Maximum Strength Lidocaine Cold & Hot Patch (lidocaine 4%, menthol 1%), 5 patches per box, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895; NDC 66902-218-05.
D-1280-2020
Product summary
- Event
- Event 85726
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 72,600 boxes
- Official record key
drug-enforcement:D-1280-2020
Official wording
Reason: 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.
Code information: Batch #: 170614, Exp 2020.06.13; 180108, Exp 2021.01.07; 180109, Exp 2021.01.08; 180110, Exp 2021.01.09; 180111, Exp 2021.01.10, 180112, Exp 2021.01.11; 180113, Exp 2021.01.12; 180317, Exp 2021.03.16; 180318, Exp 2021.03.17
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Manufacturing or process control
CGMP Deviations