Drug recall
ACETAZOLAMIDE, LYOPHILIZED 500MG INJECTABLE10 VIAL, 4 VIAL, 5 VIAL, 6 VIAL, 8 VIAL (5 DIFFERENT PRODUCTS)
FDA recall event 62416 · Class II · Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Key facts
| Event ID | 62416 |
|---|---|
| Recall numbers | D-1447-2012, D-1448-2012, D-1449-2012, D-1450-2012, D-1451-2012, D-1452-2012, D-1453-2012, D-1454-2012, D-1455-2012, D-1456-2012, D-1457-2012, D-1458-2012 and 88 more |
| Recalling firm | Franck's Lab Inc., d.b.a. Franck's Compounding Lab |
| Product type | Drugs |
| Products | ACETAZOLAMIDE, LYOPHILIZED 500MG INJECTABLE10 VIAL, 4 VIAL, 5 VIAL, 6 VIAL, 8 VIAL (5 DIFFERENT PRODUCTS), ACETIC ACID, IRRIGATION 3% SOLUTION 500 ML (1 PRODUCT), ACETYLCYSTEINE, OPHTHALMIC IN ARTIFICIAL TEARS 10% SOLUTION 10 ML, 2 ML, 5 ML, 6 ML; ACETYLCYSTEINE, OPHTHALMIC IN ARTIFICIAL TEARS 2.5% SOLUTION 20 ML; ACETYLCYSTEINE, OPHTHALMIC IN ARTIFICIAL TEARS…, ACYCLOVIR OPHTHALMIC 3% OINTMENT 5 GM; ACYCLOVIR OPHTHALMIC 3% SOLUTION 5 ML (2 DIFFERENT PRODUCTS), AFLIBERCEPT, SDPF - (0.05ML SYRINGE, 31G, 5/16") 40MG/ML INJECTABLE 0.35 ML, 0.95 ML, 1.25 ML (3 DIFFERENT PRODUCTS) and 95 more |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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 because FDA environmental sampling revealed the presence… |
| Initiation date | May 25, 2012 |
| Report date | Aug 22, 2012 |
| Termination date | Aug 13, 2014 |
| City | Ocala |
| State | FL |
| Country | United States |
| FEI number | 3006228598 |
At a glance
- 100–999 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: