Drug recall
BAYER Spectam Injectable (spectinomycin) 100 mg/ml, packaged in 500 ml rubber-stopped glass bottles, Net…
FDA recall event 70519 · Class II · Bayer Healthcare Animal Health Inc
Key facts
| Event ID | 70519 |
|---|---|
| Recall numbers | V-076-2016 |
| Recalling firm | Bayer Healthcare Animal Health Inc |
| Product type | Veterinary |
| Products | BAYER Spectam Injectable (spectinomycin) 100 mg/ml, packaged in 500 ml rubber-stopped glass bottles, Net Contents: 500 ml (NDC 0859-2383-01), NADA 040-040. The responsible name on the firm is Bayer… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Product did not meet stability specifications; an out of specification result was reported for a known impurity at the 6 month time point. |
| Initiation date | Feb 27, 2015 |
| Report date | Nov 25, 2015 |
| Termination date | Dec 8, 2016 |
| City | Saint Joseph |
| State | MO |
| Country | United States |
| FEI number | 1000118231 |
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: