Why it was recalled
Incorrect Product Formulation: An incorrect gas was used to remove the oxygen from the vial.
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.
Lot numbers, UPCs & expiration codes
Lot #: 11142014@5, 10142014@17, 11032014@13, 08262014@6, 09162014@6, 06272014@12, 08052014@5, 07222014@18, 07222014@3, 06262014@11, 06182014@3
Where it was sold
KS, MO, and TX.
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-0335-2015
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Dec 12, 2014
- FDA report date
- Jan 14, 2015
- Quantity
- a) 26 vials, b) 15 vials, c) 16 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Right Value Drug Stores, Inc.
Original FDA data
Every field from FDA enforcement report D-0335-2015, exactly as published.
Show all FDA fields
- City
- Hurst
- State
- TX
- Status
- Terminated
- Country
- United States
- Event ID
- 70003
- Address
- 122 Grapevine Hwy
- 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
- Postal code
- 76054-2406
- Report date
- Jan 14, 2015
- Product type
- Drugs
- Recall number
- D-0335-2015
- Classification
- Class II
- Recalling firm
- Right Value Drug Stores, Inc.
- Product quantity
- a) 26 vials, b) 15 vials, c) 16 vials
- Termination date
- Nov 23, 2016
- Reason for recall
- Incorrect Product Formulation: An incorrect gas was used to remove the oxygen from the vial.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- KS, MO, and TX.
- Recall initiation date
- Dec 12, 2014
- Initial firm notification
- Telephone
- Center classification date
- Jan 8, 2015