Why it was recalled
Lack of Assurance of Sterility
Product description
All products, Rx Only Manufactured by Specialty Compounding, 211 S. Bell Blvd, Cedar Park, TX 78613
Lot numbers, UPCs & expiration codes
ALL lots of product on the market as of August 9, 2013.
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-0231-2015
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 9, 2013
- FDA report date
- Nov 5, 2014
- Quantity
- Undetermined
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Specialty Compounding, LLC
Original FDA data
Every field from FDA enforcement report D-0231-2015, exactly as published.
Show all FDA fields
- City
- Cedar Park
- State
- TX
- Status
- Terminated
- Country
- United States
- Event ID
- 65953
- Address
- 211 South Bell (Hwy 183 N)
- Code information
- ALL lots of product on the market as of August 9, 2013.
- Postal code
- 78613
- Report date
- Nov 5, 2014
- Product type
- Drugs
- Recall number
- D-0231-2015
- Classification
- Class II
- Recalling firm
- Specialty Compounding, LLC
- Product quantity
- Undetermined
- Termination date
- Sep 22, 2016
- Reason for recall
- Lack of Assurance of Sterility
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- All products, Rx Only Manufactured by Specialty Compounding, 211 S. Bell Blvd, Cedar Park, TX 78613
- Distribution pattern
- Nationwide
- Recall initiation date
- Aug 9, 2013
- Initial firm notification
- Press Release
- Center classification date
- Oct 30, 2014