TRIAMCINOLONE ACETONIDE 4MG/ML (0.4MG/0.1ML) INJECTABLE 10 ML 5 ML TRIAMCINOLONE ACETONIDE (T...
FDA Drug Recall #D-1628-2012 — Class II — May 21, 2012
Recall Summary
| Recall Number | D-1628-2012 |
| 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 | 87 units |
Product Description
TRIAMCINOLONE ACETONIDE 4MG/ML (0.4MG/0.1ML) INJECTABLE 10 ML 5 ML TRIAMCINOLONE ACETONIDE (T), STSL (0.025ML SYRINGE, 30G, 1/2") 40MG/ML (4MG/0.1M 0.075 SYR 0.1 SYR TRIAMCINOLONE ACETONIDE 0.25ML SYRINGE (T) 40MG/ML (4MG/0.1ML) OPHTHALMIC 0.25 ML 0.5 ML TRIAMCINOLONE ACETONIDE 20MG/ML INJECTABLE 1 ML TRIAMCINOLONE ACETONIDE 80MG/ML INJECTABLE 100 ML TRIAMCINOLONE ACETONIDE IN VITREOUS VEHICLE, P.F. 10MG/ML (1MG/0.1ML) OPHTHALMIC 0.1 ML 50 ML TRIAMCINOLONE ACETONIDE IN VITREOUS VEHICLE, P.F. 20MG/ML (2MG/0.1ML) OPHTHALMIC 0.1 ML 0.2 ML TRIAMCINOLONE ACETONIDE IN VITREOUS VEHICLE, P.F. 40MG/ML (4MG/0.1ML) OPHTHALMIC 0.05 ML 0.1 ML 0.15 ML 0.2 ML 0.25 ML 0.5 ML 0.6 ML 0.75 ML 0.8 ML 0.9 ML 1 ML 1.2 ML 1.25 ML 10 ML 14 ML 2 ML 2.5 ML 3 ML 30 ML 360 ML 4 ML 5 ML 6 ML 8 ML TRIAMCINOLONE ACETONIDE IN VITREOUS VEHICLE, P.F. 80MG/ML (8MG/0.1ML) OPHTHALMIC 0.25 ML 0.3 ML 0.5 ML 0.75 ML 2 ML TRIAMCINOLONE ACETONIDE P.F. (OPHTHALMIC) 40MG/ML (4MG/0.1ML) OPHTHALMIC 1 ML 10 ML TRIAMCINOLONE ACETONIDE, P.F. 80MG/ML INJECTABLE 150 ML 75 ML TRIAMCINOLONE DIACETATE 40MG/ML INJECTABLE 3 ML 4 ML TRIAMCINOLONE DIACETATE, PRESERVATIVE FREE 40MG/ML INJECTABLE 360 ML (48 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: 0387290 0387290 0400922 0405419 0362272 0362272 0392196 0392211 0389062 0402046 0366190 0376388 0377225 0363673 0355420 0394877 0359658 0361833 0376569 0390305 0394394 0394710 0397895 0399493 0402872 0403787 0394877 0365100 0390365 0391344 0391346 0391866 0405531 0355420 0399719 0365828 0394562 0380506 0406925 0398935 0387737 0387737 0401220 0404375 0387737 0395444 0398847 0360739 0365769 0365769 0404497 0407975 0408999 0351511 0398847 0361324 0403770 0410188 0405655 0365764 0403770 0406991 0365769 0403770 0407885 0403574 0403577 0404165 0403579 0392063 0400699 0397870 0397870 0402420 0402420 0406941
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.