Why it was recalled
Lack of sterility assurance.
Product description
Hyaluronidase 150 units/mL 1ml. Rx Only. Packaged in 1 mL vials. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247
Lot numbers, UPCs & expiration codes
Lot: 58895:42 Use By: 06/27/2018
Where it was sold
Texas
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-1058-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 17, 2018
- FDA report date
- Aug 15, 2018
- Quantity
- 2 1-ml vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Guardian Pharmacy Services
Original FDA data
Every field from FDA enforcement report D-1058-2018, exactly as published.
Show all FDA fields
- City
- Dallas
- State
- TX
- Status
- Terminated
- Country
- United States
- Event ID
- 80118
- Address
- 7920 Elmbrook Dr Ste 108
- Code information
- Lot: 58895:42 Use By: 06/27/2018
- Postal code
- 75247-4933
- Report date
- Aug 15, 2018
- Product type
- Drugs
- Recall number
- D-1058-2018
- Classification
- Class II
- Recalling firm
- Guardian Pharmacy Services
- Product quantity
- 2 1-ml vials
- Termination date
- Nov 25, 2020
- Reason for recall
- Lack of sterility assurance.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Hyaluronidase 150 units/mL 1ml. Rx Only. Packaged in 1 mL vials. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247
- Distribution pattern
- Texas
- Recall initiation date
- May 17, 2018
- Initial firm notification
- Letter
- Center classification date
- Aug 8, 2018