Drug recall
PROPRANOLOL HYDROCHLORIDE INJECTION, USP 1 mg/mL, 1 mL Single Dose Vial, Rx only, APP Pharmaceuticals, LLC…
FDA recall event 68910 · Class II · Fresenius Kabi USA, LLC
Key facts
| Event ID | 68910 |
|---|---|
| Recall numbers | D-1545-2014 |
| Recalling firm | Fresenius Kabi USA, LLC |
| Product type | Drugs |
| Products | PROPRANOLOL HYDROCHLORIDE INJECTION, USP 1 mg/mL, 1 mL Single Dose Vial, Rx only, APP Pharmaceuticals, LLC Schaumburg, IL 60173, NDC 63323-604-01 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | CGMP Deviations: Citations given to API supplier by the Italian Health Agency AIFA for several critical deficiencies which caused a recall of the API lot used to manufacture Propanolo HCl Injection. |
| Initiation date | Aug 13, 2014 |
| Report date | Aug 27, 2014 |
| Termination date | May 24, 2016 |
| City | Melrose Park |
| State | IL |
| Country | United States |
| FEI number | 1000115163 |
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 · Source date: