Drug recall
GLADES brand Ammonium Lactate 12% Lotion in 225 gram, NDC 59366-4100-2, and 400 gram bottles, NDC…
FDA recall event 35622 · Class III · Bristol-Myers Squibb Company
Key facts
| Event ID | 35622 |
|---|---|
| Recall numbers | D-272-6, D-273-6 |
| Recalling firm | Bristol-Myers Squibb Company |
| Product type | Drugs |
| Products | GLADES brand Ammonium Lactate 12% Lotion in 225 gram, NDC 59366-4100-2, and 400 gram bottles, NDC 59366-4100-4, Rx only --- Firms on label: Marketed by: Glades Pharmaceuticals, LLC Coral Gables, FL…, Lac-Hydrin¿ 12% (ammonium lactate) Lotion, 225 gram bottle, Rx only, NDC 00072-5712-08 --- Firm on label: Bristol-Myers Squibb Company Princeton, NJ 08543 USA |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Lots did not meet specification for viscosity (low). |
| Initiation date | Jun 1, 2006 |
| City | New Brunswick |
| Country | United States |
| FEI number | 2211101 |
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