FDA recall D-0188-2018

KRS Global Biotechnology, Inc · Class II · drug

Product

Progesterone 3% 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

Nationwide in the USA, Bermuda, and New Zealand

Key facts

Status
Terminated
Initiation date
2017-11-16
Report date
2018-01-17
Termination date
2020-05-11
Voluntary/Mandated
Voluntary: Firm initiated
Location
Boca Raton, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0188-2018