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Recall Observatory FDA recall evidence

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

D-1233-2015

July 06, 2015

Class III

Product summary

Firm
BioComp Pharma, Inc.
Event
Event 71576
Status
Terminated
Classification
Class III
Quantity
40,000 sachets
Official record key
drug-enforcement:D-1233-2015

Official wording

Reason: Subpotent Drug: menthol and methyl salicylate below specification

Code information: Lot #: 4D040, Exp 4/2016

Distribution pattern: Nationwide

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Subpotent