Class III · Low risk
NORepinephrine Bitartrate
Subpotent Drug; confirmed results by FDA analysis after customer complaints of discoloration
Maximum Strength Analgesic Thera-Gesic Pain Relieving Creme…
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Subpotent Drug: menthol and methyl salicylate below specification
Cause type: Wrong potency / content
Sub- or super-potent product, or a failed content-uniformity / assay test. You may receive too little or too much active ingredient - a direct dosing risk. All wrong potency / content recalls.
What was recalled
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
Affected NDC
0178-0320-12
Compare with the code on your package — it is the most precise check available.
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Theragesic Methyl Salicylate NDC 00178-0320 |
150 mg/g; MENTHOL 10 mg/g | Cream Topical |
Mission Pharmacal Company | OTC |
- Recalling firm
- BioComp Pharma, Inc.
- NDC code
- 0178-0320-12
- Origin
- TX, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1233-2015 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other wrong potency / content recalls from 2015
All wrong potency / content recalls
Class III · Low risk
NORepinephrine Bitartrate
Subpotent Drug; confirmed results by FDA analysis after customer complaints of discoloration
Class III · Low risk
Lindane Lotion
Super-Potent Drug: Out of Specification Assay test results were reported for stability samples.
Class I · High risk
Vitamin Supplement
Superpotent Drug: The vitamin supplement contains an extremely high level of vitamin D3 (Cholecalciferol).
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