Why it was recalled
Lack of Assurance of Sterility
Product description
Autologous Serum Tears, 2 vials, Rx, Vital Care Compounder, Hattiesburg, MS 39402
Lot numbers, UPCs & expiration codes
Lot#: 390325, Use by 08/01/16; 382789, Use by 08/07/16; 396766, Use by 08/11/16; 393470, Use by 08/14/16; 393036, Use by 08/14/16; 398131, Use by 08/15/16; 389288, Use by 08/20/16; 392969, Use by 08/21/16
Where it was sold
MS
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-1541-2016
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 26, 2016
- FDA report date
- Oct 5, 2016
- Quantity
- 8 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Pharmacy Plus, Inc. dba Vital Care Compounder
Original FDA data
Every field from FDA enforcement report D-1541-2016, exactly as published.
Show all FDA fields
- City
- Hattiesburg
- State
- MS
- Status
- Terminated
- Country
- United States
- Event ID
- 75164
- Address
- 115 S 40th Ave
- Code information
- Lot#: 390325, Use by 08/01/16; 382789, Use by 08/07/16; 396766, Use by 08/11/16; 393470, Use by 08/14/16; 393036, Use by 08/14/16; 398131, Use by 08/15/16; 389288, Use by 08/20/16; 392969, Use by 08/21/16
- Postal code
- 39402-6600
- Report date
- Oct 5, 2016
- Product type
- Drugs
- Recall number
- D-1541-2016
- Classification
- Class II
- Recalling firm
- Pharmacy Plus, Inc. dba Vital Care Compounder
- Product quantity
- 8 bottles
- Termination date
- Nov 18, 2016
- Reason for recall
- Lack of Assurance of Sterility
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Autologous Serum Tears, 2 vials, Rx, Vital Care Compounder, Hattiesburg, MS 39402
- Distribution pattern
- MS
- Recall initiation date
- Jul 26, 2016
- Initial firm notification
- Telephone
- Center classification date
- Sep 27, 2016