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BRILLIANT BLUE G, P.F. 0.025% OPHTHALMIC 10 ML, 20 ML, 26 ML, 4 ML; BRILLIANT BLUE G, P.F. (0.5...

FDA Drug Recall #D-1468-2012 — Class II — May 25, 2012

Recall Summary

Recall Number D-1468-2012
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 107 units

Product Description

BRILLIANT BLUE G, P.F. 0.025% OPHTHALMIC 10 ML, 20 ML, 26 ML, 4 ML; BRILLIANT BLUE G, P.F. (0.5ML SYRINGE) 0.25MG/ML OPHTHALMIC 2 ML, 2.5 ML, 5 ML; BRILLIANT BLUE G, P.F. (0.5ML SYRINGE) 0.5MG/ML OPHTHALMIC 1.5 ML; BRILLIANT BLUE G, P.F. (0.5ML SYRINGE) 1% OPHTHALMIC 0.5 ML,1 ML,1.5 ML, 2 ML, 3 ML, 5 ML, 6 ML, 8 ML; BRILLIANT BLUE G, P.F. (STSL) (0.5ML SYRINGE) 0.025% OPHTHALMIC 2.5 ML, 5 ML; BRILLIANT BLUE G, P.F. (STSL) (0.5ML SYRINGE) 0.15% OPHTHALMIC 2.5 ML; BRILLIANT BLUE G, P.F. 0.25% OPHTHALMIC 1 ML, 10 ML, 20 ML; BRILLIANT BLUE G, P.F. 0.5% OPHTHALMIC 1 ML, 10 ML, 20 ML, 5 ML; BRILLIANT BLUE G, P.F. 1% OPHTHALMIC 10 ML, 12 ML, 15 ML, 2 ML, 2 MLS, 20 ., 20 ML, 30 ML, 4 ML, 40 ML, 50 ML, 6 ML, 80 ML, 9 ML; BRILLIANT BLUE G, P.F. 2% OPHTHALMIC 11 MLS, 15 MLS (43 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: 0387683 0393065 0394633 0385938 0387683 0385222 0394375 0389789 0394526 0391261 0399698 0380189 0387389 0384308 0387389 0390830 0370011 0386507 0394133 0397580 0386507 0393521 0374071 0396478 0360399 0377887 0382420 0360399 0382420 0373839 0373839 0367517 0395929 0396303 0398978 0398980 0398983 0398987 0398061 0395908 0366449 0366449 0385953 0395908 0368413 0386587 0387945 0388529 0388631 0390720 0392250 0393056 0395446 0397146 0397459 0399806 0354531 0397967 0399668 0387481 0394553 0396177 0398687 0395424 0388631 0369860 0381370 0388529 0388631 0390143 0392319 0392455 0381370 0393958 0393960 0395294 0396324 0397146 0397149 0389458 0390143 0357319 0369209 0389845 0396123 0360125 0366749 0366749

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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