Glutathione 200 mg/mL Injectable, packaged in a) 5 mL MDV (multiple dose vials), b) 30 mL MDV (mu...

FDA Drug Recall #D-0335-2015 — Class II — December 12, 2014

Recall Summary

Recall Number D-0335-2015
Classification Class II — Moderate risk
Date Initiated December 12, 2014
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Right Value Drug Stores, Inc.
Location Hurst, TX
Product Type Drugs
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.

Lot / 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

Other Recalls from Right Value Drug Stores, Inc.

Recall # Classification Product Date
D-0243-2019 Class III Tadalafil SR 12 mg Capsules packed in 8,13, 20,... Sep 25, 2018
D-0241-2019 Class III Progesterone SR 200 mg Capsules, packed in 8,13... Sep 25, 2018
D-0242-2019 Class III Tadalafil SR 7 mg Capsules packed in 8,13, 20, ... Sep 25, 2018
D-0240-2019 Class III Progesterone SR 100 mg Capsules, packed in 8,13... Sep 25, 2018
D-1047-2018 Class III Testosterone 200 mg Pellet, Rx only, Carie Boyd... Jul 26, 2018

Frequently Asked Questions

Stop taking the medication and contact your pharmacist or doctor immediately. For Class I recalls, this is urgent. For Class II or III recalls, consult your doctor before stopping — abruptly discontinuing certain medications (blood pressure drugs, antidepressants, diabetes medications) can be more harmful than continuing while arranging a replacement. Check whether the recall applies to your specific lot number and expiration date. Return the product to your pharmacy and report any adverse effects to FDA MedWatch at 1-800-FDA-1088.

Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.

Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.

What Should You Do?

Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.