Drug recall
AIRACOF LIQUID C-V, 16 fl. oz, Rx, Manufactured For: Centurion Labs, LLC, Birmingham, AL 35243. NDC…
FDA recall event 58065 · Class II · Deltex Pharmaceuticals, Inc
Key facts
| Event ID | 58065 |
|---|---|
| Recall numbers | D-462-2011, D-463-2011, D-464-2011, D-465-2011, D-466-2011, D-467-2011, D-468-2011, D-469-2011, D-470-2011, D-471-2011, D-472-2011, D-473-2011 and 25 more |
| Recalling firm | Deltex Pharmaceuticals, Inc |
| Product type | Drugs |
| Products | AIRACOF LIQUID C-V, 16 fl. oz, Rx, Manufactured For: Centurion Labs, LLC, Birmingham, AL 35243. NDC 23359-019-16, Breckenridge Pharmaceutical, Inc. Bromphenex DM, , 16 fl. oz bottles, Rx only, Manufactured by: Deltex Pharmaceuticals, Rosenberg, TX 77471 NDC 51991-147-16, Breckenridge Pharmaceutical Inc. Coldcough PD Syrup C-V, 4 fl. oz bottle, Rx only, Manufactured by: Deltex Pharmaceuticals Inc., Rosenberg, TX 77471 NDC 51991-224-04, Breckenridge Pharmaceutical Inc., Coldcough Syrup C-III, , 16 fl. oz, Rx, Manufactured by: Deltex Pharmaceuticals, Inc., Rosenberg, TX 77471 NDC 51991-222-16, Breckenridge Pharmaceutical Inc, Dexphen w/C Liquid C-V, 16 fl oz, OTC, Manufactured for Breckenridge Pharmaceutical, Inc., Boca Raton FL 33487 NDC 51991-729-16 and 32 more |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | FDA Requested |
| Reason for recall | CGMP Deviations: Firm failed to comply with current good manufacturing practice requirements. |
| Initiation date | Feb 28, 2011 |
| Termination date | Sep 9, 2013 |
| City | Rosenberg |
| State | TX |
| Country | United States |
| FEI number | 3003499272 |
At a glance
- 10–99 Products in this recall
- 1–9 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