Reported Aug 22, 2012 · Terminated

TRIAMCINOLONE ACETONIDE 4MG/ML (0.4MG/0.1ML) INJECTABLE 10 ML 5 ML TRIAMCINOLONE ACETONIDE (T), STSL (0.025ML SYRINGE,…

Franck's Lab Inc., d.b.a. Franck's Compounding Lab

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Franck's Lab Inc., d.b.a. Franck's Compounding Lab · 1210 SW 33rd Avenue · Ocala, FL · 34474-5138

Is this the product you have?

3 of 3 products · 9 lot codes

Recalled lot codes, grouped by product number
Product number	Lot codes and dates
`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

Lot codes and dates: Rx #'s:
76 of 76 codes
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
Amount recalled: 87 units

This recall covers 198 products

The agency filed one notice per product. You are reading one of them; the other 197 are below.

185 more are in the archive.

Where it was sold

Nationwide

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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