BioComp Pharma Recalls Subpotent Thera-Gesic Pain Relieving Creme Sachets
BioComp Pharma is recalling 40,000 sachets of Thera-Gesic Pain Relieving Creme because the active ingredients menthol and methyl salicylate are below specification.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class III, which indicates the product is not likely to cause adverse health consequences. The hazard is a lack of efficacy (subpotency) rather than a direct safety risk like toxicity or contamination.
Plain-English summary
BioComp Pharma, Inc. is recalling 40,000 sachets of Maximum Strength Analgesic Thera-Gesic Pain Relieving Creme. The product is an over-the-counter medication intended for relief from joint and muscle soreness, arthritis, and back aches. The specific lot number is 4D040, with an expiration date of 4/2016.
The recall was initiated because the active ingredients menthol and methyl salicylate were found to be below specification, making the product subpotent. This means the medication may not provide the intended therapeutic effect. The affected products were distributed nationwide.
Consumers who have this product should stop using it and return it to the place of purchase for a refund or contact the recalling firm for further instructions.
The recalled product
- 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…
- Manufacturer
- BioComp Pharma, Inc.
- Category
- Drug — Topical Analgesic
- Hazard
- Affected units
- 40,000
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: 4D040
- Exp 4/2016
Distribution
Distributed nationwide across the United States.
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