Triamcinolone Acetonide (Franck's Lab) – sterility concerns (2012)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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 ACETON
Brand
Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
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
Franck's Lab Inc., d.b.a. Franck's Compounding Lab is recalling TRIAMCINOLONE ACETONIDE 4MG/ML (0.4MG/0.1ML) INJECTABLE 10 ML 5 ML TRIAMCINOLONE ACETONIDE (T), due to 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 env. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026