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TRYPAN BLUE SOLUTION, P.F. 0.04% OPHTHALMIC 10 ML; TRYPAN BLUE SOLUTION, P.F. 0.05% OPHTHALMI...

FDA Drug Recall #D-1634-2012 — Class II — May 21, 2012

Recall Summary

Recall Number D-1634-2012
Classification Class II — Moderate risk
Date Initiated May 21, 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 102 units

Product Description

TRYPAN BLUE SOLUTION, P.F. 0.04% OPHTHALMIC 10 ML; TRYPAN BLUE SOLUTION, P.F. 0.05% OPHTHALMIC 0.5 ML 1.5 ML 10 ML 12 ML 2 ML 2.5 ML 3 ML 4 ML 4.5 ML 5 ML 6 ML 7.5 ML 8 ML; TRYPAN BLUE SOLUTION, P.F. 0.06% OPHTHALMIC 10 ML 2.5 ML; TRYPAN BLUE SOLUTION, P.F. 0.1% OPHTHALMIC 1 ML 1.5 ML 10 ML 12 ML 2 ML 25 ML 4 ML 5 ML 50 ML; TRYPAN BLUE SOLUTION, P.F. STSL (0.5ML SYRINGE, NO NEEDLE) 0.06% OPHTHALMIC 10 ML; TRYPAN BLUE, 0.75ML SYRINGE, LUER-LOK, STSL 0.1% OPHTHALMIC 3 ML 4.5 ML 9 ML; TRYPAN BLUE, 1ML SYRINGE, LUER-LOK, STSL 0.1% OPHTHALMIC 12 ML (30 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. 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, West Indies

Lot / Code Information

Rx #'s: 0396447 0391904 0396678 0393251 0400335 0402500 0352474 0368241 0387963 0394942 0402089 0394942 0400335 0352474 0368241 0393251 0395043 0368241 0393251 0403936 0409994 0391904 0349660 0368241 0388163 0390614 0391904 0401994 0402332 0402500 0393985 0368241 0403168 0402227 0403032 0395193 0396679 0397454 0396679 0387480 0387514 0397147 0401881 0405105 0409255 0397147 0403630 0397147 0401846 0387647 0390992 0397147 0403742 0402848 0402848 0402848 0399288

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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