GLUTATHIONE L REDUCED 100MG/ML (2ML NEBVL) INHALATION; GLUTATHIONE L REDUCED 200MG/ML (1ML NEBVL)...
FDA Drug Recall #D-0210-2023 — Class II — December 22, 2022
Recall Summary
| Recall Number | D-0210-2023 |
| Classification | Class II — Moderate risk |
| Date Initiated | December 22, 2022 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Pharmacy Innovations |
| Location | Erie, PA |
| Product Type | Drugs |
| Quantity | N/A |
Product Description
GLUTATHIONE L REDUCED 100MG/ML (2ML NEBVL) INHALATION; GLUTATHIONE L REDUCED 200MG/ML (1ML NEBVL) INHALATION; GLUTATHIONE L REDUCED 220MG/ML (30ML VIAL) INJECTABLE; GLUTATHIONE L REDUCED 500MG/ML (1ML VIAL) INJECTABLE; GLUTATHIONE L REDUCED 500MG/ML (2ML VIAL) INJECTABLE; GLUTATHIONE L REDUCED-PF- 200MG/ML (2ML VIAL) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Reason for Recall
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Distribution Pattern
Nationwide in the USA
Lot / Code Information
t20221129@68 t20221025@32 t20221025@33 t20221114@27 t20221021@40 t20221116@36
Other Recalls from Pharmacy Innovations
| Recall # | Classification | Product | Date |
|---|---|---|---|
| D-0220-2023 | Class II | METHION/INOSIT/CHOLINE/CYANOCOBAL 25MG/50MG/50M... | Dec 22, 2022 |
| D-0194-2023 | Class II | Atropine sulfate 0.05%, 1ML dropper, and Atropi... | Dec 22, 2022 |
| D-0240-2023 | Class II | TOBRAMYCIN FORTIFIED 15MG/ML OPH SOLUTION, Rx O... | Dec 22, 2022 |
| D-0191-2023 | Class II | Acetylcysteine 10% Ophthalmic Solution, Rx Only... | Dec 22, 2022 |
| D-0228-2023 | Class II | PE1/PAPAV/PHEN 20MCG/30MG/2MG/ML (1ML VIAL) INJ... | Dec 22, 2022 |
Frequently Asked Questions
Injectable drugs and eye drops must be completely free of microbial contamination because they bypass the body's natural defenses. A contaminated injectable can introduce bacteria or fungi directly into the bloodstream, potentially causing sepsis, meningitis, or localized infections — all of which can be life-threatening. Contamination of sterile products almost always results in a Class I recall. If you received an injectable drug from a recalled lot, contact your healthcare provider immediately, even if you feel well, as some infections can have delayed onset.
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.