Drug product
Medline Remedy Essential Barrier Skin Protectant Ointment (petrolatum 59%) packaged in a) 2 oz tubes (NDC 53329-302-14) and b) 6 oz tubes (NDC 53329-302-41), Medline Industries Inc., Manufactured for Medline Industries Inc., Mundelien, IL 60060.
D-0427-2019
Product summary
- Event
- Event 81784
- Status
- Terminated
- Classification
- Class II
- Quantity
- 7020 units
- Official record key
drug-enforcement:D-0427-2019
Official wording
Reason: GMP Deviations: Out of specification results for Total Aerobic Microbial count in excipient purified water sample
Code information: Lot # a) and b): 44G17, Exp. 05/2019
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Manufacturing or process control
GMP Deviations
-
Potency or specification failure
Out of specification