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EDTA DISODIUM SOLUTION 33.6MG/ML (0.1 MOLAR) OPHTHALMIC 15 ML; EDTA CALCIUM DISODIUM (PRESERVAT...

FDA Drug Recall #D-1512-2012 — Class II — May 25, 2012

Recall Summary

Recall Number D-1512-2012
Classification Class II — Moderate risk
Date Initiated May 25, 2012
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Location Ocala, FL
Product Type Drugs
Quantity 28 units

Product Description

EDTA DISODIUM SOLUTION 33.6MG/ML (0.1 MOLAR) OPHTHALMIC 15 ML; EDTA CALCIUM DISODIUM (PRESERVATIVE FREE) 150MG/ML INJECTABLE 100 ML, 2400 ML, 500 ML; EDTA CALCIUM DISODIUM SOLUTION 2% OPHTHALMIC 5 ML; EDTA DISODIUM (P.F.) 150MG/ML INJECTABLE 1000 ML, 1200 ML, 1500 ML, 400 ML, 500 ML, 900 ML; EDTA DISODIUM (PRESERVATIVE FREE) 150MG/ML INJECTABLE 1000 ML, 2000 ML, 8000 ML; EDTA DISODIUM (PRESERVATIVE FREE) 3%/ML INJECTABLE 12 ML; EDTA DISODIUM IN NATURAL TEARS 1.5% OPHTHALMIC 5 ML; EDTA DISODIUM IN NATURAL TEARS 3% OPHTHALMIC 15 ML, 30 ML (18 DIFFERENT PRODUCTS)

Reason for Recall

Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.

Distribution Pattern

Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, and West Indies

Lot / Code Information

Rx #'s: 0388316 0388963 0389126 0389635 0391611 0406215 0395252 0392864 0395978 0390748 0390748 0390748 0391630 0391630 0390748 0400319 0388489 0388489 0389320 0390209 0403997 0382211 0381428

Other Recalls from Franck's Lab Inc., d.b.a. Franck's Co...

Recall # Classification Product Date
D-1513-2012 Class II ENGERIX-B, SDV** 20MCG/ML INJECTABLE 1 ML (1 PR... May 25, 2012
D-1452-2012 Class II ALPROSTADIL 10MCG/ML INJECTABLE 10 ML, 20 ML, ... May 25, 2012
D-1514-2012 Class II EPINEPHRINE **(25X1ML AMPULS) 1:1000 1MG/ML INJ... May 25, 2012
D-1451-2012 Class II AFLIBERCEPT, SDPF - (0.05ML SYRINGE, 31G, 5/16"... May 25, 2012
D-1492-2012 Class II CYCLOPENT/PHENYLEPH/TROPICAMIDE/PROPARACAINE 2%... May 25, 2012

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.

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