Glutathione PF, 60 mg/mL inhalation, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafa...

FDA Drug Recall #D-423-2014 — Class II — October 19, 2013

Recall Summary

Recall Number D-423-2014
Classification Class II — Moderate risk
Date Initiated October 19, 2013
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Specialty Medicine Compounding Pharmacy
Location South Lyon, MI
Product Type Drugs
Quantity 126 mL

Product Description

Glutathione PF, 60 mg/mL inhalation, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

Reason for Recall

Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.

Distribution Pattern

Hospitals, clinics, physicians, and patients in the Michigan area only.

Lot / Code Information

All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #: 10112013@1

Other Recalls from Specialty Medicine Compounding Pharmacy

Recall # Classification Product Date
D-458-2014 Class II 0.9% Sodium chloride a) DT-0.9% Sodium chloride... Oct 19, 2013
D-414-2014 Class II Combo Eye Gel, HF COMBO EYE GEL* (cyclopentolat... Oct 19, 2013
D-457-2014 Class II Calcium Chloride* PF 500 mg/mL pref syringe, Rx... Oct 19, 2013
D-451-2014 Class II TRANEXAMIC ACID* 2 g/75 mL SOLUTION, Rx only, ... Oct 19, 2013
D-410-2014 Class II Acetylcysteine (PF) 20 % Opthalmic, Rx only, Sp... Oct 19, 2013

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.