Why it was recalled
Subpotent Drug: menthol and methyl salicylate below specification
Product description
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
Lot numbers, UPCs & expiration codes
Lot #: 4D040, Exp 4/2016
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1233-2015
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jul 6, 2015
- FDA report date
- Jul 15, 2015
- Quantity
- 40,000 sachets
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- BioComp Pharma, Inc.
Original FDA data
Every field from FDA enforcement report D-1233-2015, exactly as published.
Show all FDA fields
- City
- San Antonio
- State
- TX
- Status
- Terminated
- Country
- United States
- Event ID
- 71576
- Address
- 10999 IH 10 West
- Address (line 2)
- Suite 1000
- Code information
- Lot #: 4D040, Exp 4/2016
- Postal code
- 78230
- Report date
- Jul 15, 2015
- Product type
- Drugs
- Recall number
- D-1233-2015
- Classification
- Class III
- Recalling firm
- BioComp Pharma, Inc.
- Product quantity
- 40,000 sachets
- Termination date
- Jun 24, 2016
- Reason for recall
- Subpotent Drug: menthol and methyl salicylate below specification
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide
- Recall initiation date
- Jul 6, 2015
- Initial firm notification
- Letter
- Center classification date
- Jul 9, 2015