Drug recall
Aerozoin,Skin Conditioner For Tape & Cast Dressings, (Tinture of Benzoin, USP 40%), Net Wt. 3.5 oz., spray…
FDA recall event 25059 · Class III · Pel Associates Inc
Key facts
| Event ID | 25059 |
|---|---|
| Recall numbers | D-128-3, D-129-3 |
| Recalling firm | Pel Associates Inc |
| Product type | Drugs |
| Products | Aerozoin,Skin Conditioner For Tape & Cast Dressings, (Tinture of Benzoin, USP 40%), Net Wt. 3.5 oz., spray can, Grafco, A Graham -Field Brand, Atlanta, GA, NDC 0534-0103-06, KENZOIN, Skin Conditioner For Tape & Cast Dressings, (Tinture of Benzoin, USP 40%), Net Wt. 4 oz. (113 Grams), Distributed By Kentron Health Care Inc., Springfield, TN 37172, NDC #58765-102-04 |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Failure to comply with Good Manufacturing Practice Regulations including performance of finished product assays & manufacturing validation. |
| Initiation date | Nov 8, 2002 |
| City | North Branch |
| Country | United States |
| FEI number | 2245514 |
At a glance
- 1–9 Products in this recall
- None 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