Why it was recalled
Lack of Assurance of Sterility: A recent FDA inspection found that this product was not being compounded in an area appropriate for lyophilization which may lead to a lack of sterility assurance.
Product description
Sermorelin 6mg/6mL Lyophilized Powder, Sterile Compound for Subcutaneous Injection, Diabetes Corporation of America dba DCA Pharmacy, Franklin, TN 37064-5527
Lot numbers, UPCs & expiration codes
Lot #: 101614, Exp 4/30/2015
Where it was sold
KY, OH, TN
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-0006-2016
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Sep 23, 2015
- FDA report date
- Oct 14, 2015
- Quantity
- 129 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Diabetes Corporation of America dba DCA Pharmacy
Original FDA data
Every field from FDA enforcement report D-0006-2016, exactly as published.
Show all FDA fields
- City
- Franklin
- State
- TN
- Status
- Terminated
- Country
- United States
- Event ID
- 72271
- Address
- 233 Bedford Way
- Code information
- Lot #: 101614, Exp 4/30/2015
- Postal code
- 37064-5527
- Report date
- Oct 14, 2015
- Product type
- Drugs
- Recall number
- D-0006-2016
- Classification
- Class II
- Recalling firm
- Diabetes Corporation of America dba DCA Pharmacy
- Product quantity
- 129 vials
- Termination date
- Jan 12, 2016
- Reason for recall
- Lack of Assurance of Sterility: A recent FDA inspection found that this product was not being compounded in an area appropriate for lyophilization which may lead to a lack of sterility assurance.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Sermorelin 6mg/6mL Lyophilized Powder, Sterile Compound for Subcutaneous Injection, Diabetes Corporation of America dba DCA Pharmacy, Franklin, TN 37064-5527
- Distribution pattern
- KY, OH, TN
- Recall initiation date
- Sep 23, 2015
- Initial firm notification
- Telephone
- Center classification date
- Oct 5, 2015