D-0167-2018 Class II Terminated
FDA drug recall D-0167-2018 was initiated by KRS Global Biotechnology, Inc on Nov 16, 2017 and is designated Class II. Reason for recall: Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product. The recall status is terminated (terminated May 11, 2020). Affected quantity: 3,280 jars.
Recall Details
- Product Type
- Drugs
- Report Date
- Jan 17, 2018
- Initiation Date
- Nov 16, 2017
- Termination Date
- May 11, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3,280 jars
Product Description
Benzo/Lido/Tetracaine 20%-8%-8% Topical Cream packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
Reason for Recall
Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Distribution Pattern
Nationwide in the USA, Bermuda, and New Zealand
Code Information
Lots: 06072017@38 BUD: 12/4/2017; 07062017@48 BUD: 1/2/2018; 08012017@23 BUD: 1/28/2018; 08212017@36 BUD: 2/17/2018; 09182017@26 BUD: 3/17/2018
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0167-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026