Drug product
Glutathione 200 mg/mL Injectable, packaged in a) 5 mL MDV (multiple dose vials), b) 30 mL MDV (multiple dose vials), and c) 100 mL MDV (multiple dose vials), Rx only, Carie Boyd's Prescription Shop, 122 Grapevine Highway, Hurst, TX 76054, (817) 282-9376.
D-0335-2015
Product summary
- Event
- Event 70003
- Status
- Terminated
- Classification
- Class II
- Quantity
- a) 26 vials, b) 15 vials, c) 16 vials
- Official record key
drug-enforcement:D-0335-2015
Official wording
Reason: Incorrect Product Formulation: An incorrect gas was used to remove the oxygen from the vial.
Code information: Lot #: 11142014@5, 10142014@17, 11032014@13, 08262014@6, 09162014@6, 06272014@12, 08052014@5, 07222014@18, 07222014@3, 06262014@11, 06182014@3
Distribution pattern: KS, MO, and TX.
Derived failure modes
-
Unknown
Incorrect Product Formulation: An incorrect gas was used to remove the oxygen from the vial.