Drug product
Soothe & Cool Protect Moisture Guard Skin Protectant (petrolatum 59%),3.5 oz tubes, Manufactured in USA for: Medline Industries, Inc., Mundelein, IL 60060 USA NDC 53329-303-22
D-0425-2019
Product summary
- Event
- Event 81784
- Status
- Terminated
- Classification
- Class II
- Quantity
- 19752 units
- Official record key
drug-enforcement:D-0425-2019
Official wording
Reason: GMP Deviations: Out of specification results for Total Aerobic Microbial count in excipient purified water sample
Code information: Lot #: 50G17, Exp. 5/2019; 76J17, Exp. 7/2019
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Manufacturing or process control
GMP Deviations
-
Potency or specification failure
Out of specification