Why it was recalled
Lack of Assurance of Sterility: preliminary environmental monitoring report exceeds limits, therefore sterility cannot be assured.
Product description
Volumex (Iodinated I 131 Albumin) Injection USP, 25 uCi per 1 mL syringe, Rx Only, Manufactured for Daxor Corp., NY, NY; By: Iso-Tex Diagnostics, Inc.; NDC 50914-7720-8.
Lot numbers, UPCs & expiration codes
Lot: V190603-922, Exp. 04/05/19
Where it was sold
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-1008-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 11, 2019
- FDA report date
- Mar 27, 2019
- Quantity
- 54 syringes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Iso-Tex Diagnostics, Inc
Original FDA data
Every field from FDA enforcement report D-1008-2019, exactly as published.
Show all FDA fields
- City
- Alvin
- State
- TX
- Status
- Terminated
- Country
- United States
- Event ID
- 82397
- Address
- 1511 County Road 129
- Code information
- Lot: V190603-922, Exp. 04/05/19
- Postal code
- 77511-1466
- Report date
- Mar 27, 2019
- Product type
- Drugs
- Recall number
- D-1008-2019
- Classification
- Class II
- Recalling firm
- Iso-Tex Diagnostics, Inc
- Product quantity
- 54 syringes
- Termination date
- Dec 15, 2020
- Reason for recall
- Lack of Assurance of Sterility: preliminary environmental monitoring report exceeds limits, therefore sterility cannot be assured.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Volumex (Iodinated I 131 Albumin) Injection USP, 25 uCi per 1 mL syringe, Rx Only, Manufactured for Daxor Corp., NY, NY; By: Iso-Tex Diagnostics, Inc.; NDC 50914-7720-8.
- Distribution pattern
- TN
- Recall initiation date
- Mar 11, 2019
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Mar 18, 2019