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U.S. Department of Health and Human Services

Enforcement Report - Week of August 22, 2012

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Product Detail

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)
Recall Number D-1628-2012
Classification Class II
Code Info 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
Product Distributed Qty 87 units
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.

Event Detail

Event Id 62443
Product Type Drugs
Status Ongoing
Recalling Firm Franck's Lab Inc., d.b.a. Franck's Compounding Lab
City Ocala
State FL
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-05-21
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, West Indies
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