FDA recall D-1233-2015

BioComp Pharma, Inc. · Class III · drug

Product

Maximum Strength Analgesic Thera-Gesic Pain Relieving Creme Relief from: Joint and Muscle Soreness, Arthritis, Back Aches; 1/8 Oz Sachet, OTC, Manufactured for Mission Pharmacal Company 10999 IH 10 West, Suite 1000 San Antonio, TX 78230 by Mission Pharmacal Company 38505 IH 10 West Boerne, TX 78006. NDC 0178-0320-12

Reason for recall

Subpotent Drug: menthol and methyl salicylate below specification

Distribution

Nationwide

Key facts

Status
Terminated
Initiation date
2015-07-06
Report date
2015-07-15
Termination date
2016-06-24
Voluntary/Mandated
Voluntary: Firm initiated
Location
San Antonio, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1233-2015