D-0335-2015 Class II Terminated
FDA drug recall D-0335-2015 was initiated by Right Value Drug Stores, Inc. on December 12, 2014 and is designated Class II. Reason for recall: Incorrect Product Formulation: An incorrect gas was used to remove the oxygen from the vial. The recall status is terminated (terminated November 23, 2016). Affected quantity: a) 26 vials, b) 15 vials, c) 16 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- January 14, 2015
- Initiation Date
- December 12, 2014
- Termination Date
- November 23, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- a) 26 vials, b) 15 vials, c) 16 vials
Product Description
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.
Reason for Recall
Incorrect Product Formulation: An incorrect gas was used to remove the oxygen from the vial.
Distribution Pattern
KS, MO, and TX.
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