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DEXAMETHASONE SODIUM PHOSPHATE PF 0.04% OPHTHALMIC 2 ML; DEXAMETHASONE / LIDOCAINE 0.5%/3% INJ...

FDA Drug Recall #D-1497-2012 — Class II — May 25, 2012

Recall Summary

Recall Number D-1497-2012
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 73 units

Product Description

DEXAMETHASONE SODIUM PHOSPHATE PF 0.04% OPHTHALMIC 2 ML; DEXAMETHASONE / LIDOCAINE 0.5%/3% INJECTABLE 30 MLS; DEXAMETHASONE ACETATE (LA) 8MG/ML INJECTABLE 100 ML; DEXAMETHASONE IONTOPHORESIS, STERILE, P.F. 4MG/ML SOLUTION 20 ML, 30 ML (35 DIFFERENT PRODUCTS) 40 ML DEXAMETHASONE SDPF (0.1ML SYRINGE, 31G, 5/16" ) 0.4MG/ML INJECTABLE 0.3 ML 0.5 ML DEXAMETHASONE SODIUM PHOSPHATE (P.F.) 10MG/ML (1%) INJECTABLE 0.05 ML 1 ML 16 ML 2 ML 24 ML 3 ML 32 ML 8 ML DEXAMETHASONE SODIUM PHOSPHATE (P.F.) 4MG/ML (0.4%) INJECTABLE 0.4 ML 2 ML 3 ML 5 ML 6 ML DEXAMETHASONE SODIUM PHOSPHATE (P.F.) 80MG/ML (8%) INJECTABLE 100 ML 40 ML DEXAMETHASONE SODIUM PHOSPHATE (P.F.) 8MG/ML (800MCG/0.1ML) INJECTABLE 0.1 ML DEXAMETHASONE SODIUM PHOSPHATE 40MG/ML INJECTABLE 50 ML DEXAMETHASONE SODIUM PHOSPHATE 4MG/ML INJECTABLE 100 ML 180 MLS 240 MLS 30 ML 60 ML DEXAMETHASONE SODIUM PHOSPHATE IN BSS (P.F.) 10MG/ML (1%) INJECTABLE 1 ML DEXAMETHASONE SODIUM PHOSPHATE, 30ML VIAL** 4MG/ML INJECTABLE 30 ML DEXAMETHASONE SOLUTION - NACL, P.F. 0.1% OPHTHALMIC 15 ML DEXAMETHASONE, SDPF - (0.07ML SYRINGE, 30G, 1/2") 80MG/ML INJECTABLE 0.35 ML 0.7 ML

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: 0406046 0397385 0366980 0395509 0387345 0387381 0387586 0387752 0391041 0391584 0394112 0394246 0395288 0397054 0397946 0399555 0400910 0401208 0403442 0404123 0408115 0388847 0388144 0388144 0395892 0389202 0373332 0378850 0388550 0392222 0373332 0378850 0388550 0373332 0373332 0378850 0358046 0376175 0392337 0375442 0392337 0377047 0381838 0388945 0407636 0371528 0375458 0375458 0400150 0368414 0366367 0389059 0392819 0407227 0368231 0390906 0405998 0364593 0409797 0364593

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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