D-0427-2019 Class II Terminated
FDA drug recall D-0427-2019 was initiated by US Pharmaceuticals Inc. on Dec 7, 2018 and is designated Class II. Reason for recall: GMP Deviations: Out of specification results for Total Aerobic Microbial count in excipient purified water sample The recall status is terminated (terminated Nov 6, 2023). Affected quantity: 7020 units.
Recall Details
- Product Type
- Drugs
- Report Date
- Feb 13, 2019
- Initiation Date
- Dec 7, 2018
- Termination Date
- Nov 6, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7020 units
Product Description
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.
Reason for Recall
GMP Deviations: Out of specification results for Total Aerobic Microbial count in excipient purified water sample
Distribution Pattern
Nationwide within the United States
Code Information
Lot # a) and b): 44G17, Exp. 05/2019
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0427-2019
- openFDA file date
- Oct 21, 2026
- Loaded by RegDataLab
- Oct 23, 2026