TRIAMCINOLONE ACETONIDE 4MG/ML — Class II drug recall D-1628-2012
Terminated recall by Franck's Lab Inc., d.b.a. Franck's Compounding Lab, reported 2012-08-22, distributed nationwide. Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed be
| Recall number | D-1628-2012 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Franck's Lab Inc., d.b.a. Franck's Compounding Lab, Ocala, FL, United States |
| Recall initiated | 2012-05-21 |
| Classified | 2012-08-10 |
| Reported by FDA | 2012-08-22 |
| Terminated | 2014-08-15 |
| Distributed | Nationwide (US) |
| Countries outside the US | BS, DO, GT, KY, PL, VE |
| Quantity | 87 units |
| Reason classes | microbial contamination, sterility |
| Pathogens | mold |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1628-2012. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.