Drug recall
12% LAC Lotion (Ammonium Lactate) Lotion RX Only, NET WT 400 g, Paddock Laboratories, Inc, Minneapolis, MN…
FDA recall event 57579 · Class III · Paddock Laboratories, Inc.
Key facts
| Event ID | 57579 |
|---|---|
| Recall numbers | D-205-2011, D-206-2011 |
| Recalling firm | Paddock Laboratories, Inc. |
| Product type | Drugs |
| Products | 12% LAC Lotion (Ammonium Lactate) Lotion RX Only, NET WT 400 g, Paddock Laboratories, Inc, Minneapolis, MN --- NDC 0574-2021-16, 12% LAC Lotion (Ammonium Lactate), RX Only, NET WT. 225 g Paddock Laboratories, Inc, Minneapolis, MN --- NDC 0574-2021-08 |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Failed impurity Specification; 18 month stability, Paddock Laboratories, Inc. initiated a recall on LAClotion 12% (ammonium Lactate) Lotion 225 gm & 400 gm. Two lots failed at the 18 month stability time point for Impurity B and Total Impurities. Five… |
| Initiation date | Dec 15, 2010 |
| Termination date | Mar 20, 2012 |
| City | Minneapolis |
| State | MN |
| Country | United States |
| FEI number | 2127022 |
At a glance
- 1–9 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