NA Ascorbate 500 mg/mL, PF, 100 mL, Medaus Pharmacy 1-800-526-9183

FDA Drug Recall #D-1054-2013 — Class II — August 23, 2013

Recall Summary

Recall Number D-1054-2013
Classification Class II — Moderate risk
Date Initiated August 23, 2013
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Medaus, Inc.
Location Birmingham, AL
Product Type Drugs
Quantity 15,500 mL

Product Description

NA Ascorbate 500 mg/mL, PF, 100 mL, Medaus Pharmacy 1-800-526-9183

Reason for Recall

Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable. Hence the sterility of the products cannot be assured.

Distribution Pattern

Nationwide

Lot / Code Information

LOT # 130702-1, Exp 12/29/2013

Other Recalls from Medaus, Inc.

Recall # Classification Product Date
D-1222-2016 Class II M.I.C B-COMPLEX PREMIX W/HYDROXY B12 W/PRES. (... May 13, 2016
D-1224-2016 Class II M.I.C 25/50/50 W/PRES. (BENZYL ETOH 2%) METHIO... May 13, 2016
D-1179-2016 Class II DEXPANTHENOL 250MG/ML W/PRES. (BENZALKONIUM CH... May 13, 2016
D-1198-2016 Class II L-GLUTATHIONE 100MG/ML (PF), 10 ML Vials, MEDA... May 13, 2016
D-1216-2016 Class II METHYL B12 10MG/ML (PF) IN NACL 0.9%, 1ML Vials... May 13, 2016

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.