Drug recall
Isopto Carpine (pilocarpine hydrochloride opthalmic solution) 4%, packaged in 15 mL bottle, Rx only…
FDA recall event 76756 · Class III · Novartis Pharmaceuticals Corp.
Key facts
| Event ID | 76756 |
|---|---|
| Recall numbers | D-0678-2017, D-0679-2017 |
| Recalling firm | Novartis Pharmaceuticals Corp. |
| Product type | Drugs |
| Products | Isopto Carpine (pilocarpine hydrochloride opthalmic solution) 4%, packaged in 15 mL bottle, Rx only, Manufactured by: Alcon Laboratories, Inc. Fort Worth Texas 76134 USA NDC 0998-0206-15, Pilocarpine Hydrochloride Ophthalmic Solution 4% , packaged in 15 mL bottles, Rx Only, Manufactured by Alcon Laboratories, Inc. Fort Worth, Texas 76134 Sandoz Princeton, NJ 08540, NDC 61314-206-15 |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Failed Impurities/Degradation Specifications. |
| Initiation date | Mar 22, 2017 |
| Report date | May 3, 2017 |
| Termination date | Feb 5, 2020 |
| City | East Hanover |
| State | NJ |
| Country | United States |
| FEI number | 2210396 |
At a glance
- 1–9 Products in this recall
- None 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: