Recalls / Class II
Class IID-0335-2015
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.
- Affected lot / code info
- Lot #: 11142014@5, 10142014@17, 11032014@13, 08262014@6, 09162014@6, 06272014@12, 08052014@5, 07222014@18, 07222014@3, 06262014@11, 06182014@3
Why it was recalled
Incorrect Product Formulation: An incorrect gas was used to remove the oxygen from the vial.
Recalling firm
- Firm
- Right Value Drug Stores, Inc.
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 122 Grapevine Hwy, N/A, Hurst, Texas 76054-2406
Distribution
- Quantity
- a) 26 vials, b) 15 vials, c) 16 vials
- Distribution pattern
- KS, MO, and TX.
Timeline
- Recall initiated
- 2014-12-12
- FDA classified
- 2015-01-08
- Posted by FDA
- 2015-01-14
- Terminated
- 2016-11-23
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0335-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.