Multi event Drug Recall Enforcement Report Class III voluntary initiated by Novartis Pharmaceuticals Corp., originally initiated on 03-22-2017 for the product 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 The product was recalled due to failed impurities/degradation specifications.. The product was distributed nationwide and the recall is currently terminated.
Recall Enforcement Reports
| Recall Number |
Recall Initiation Date |
Report Date |
Recall Classification |
Quantity |
Product Description |
Recall Reason |
Status |
| D-0679-2017 | 03-22-2017 | 05-03-2017 | Class III | N/A | 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 | Failed Impurities/Degradation Specifications. | Terminated |
| D-0678-2017 | 03-22-2017 | 05-03-2017 | Class III | N/A | 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 | Failed Impurities/Degradation Specifications. | Terminated |
Recalled Products
| NDC |
Proprietary Name |
Non-Proprietary Name |
Dosage Form |
Route Name |
Company Name |
Product Type |
| 61314-203 | Pilocarpine Hydrochloride | Pilocarpine Hydrochloride | Solution/ Drops | Ophthalmic | Sandoz Inc | Human Prescription Drug |
| 61314-204 | Pilocarpine Hydrochloride | Pilocarpine Hydrochloride | Solution/ Drops | Ophthalmic | Sandoz Inc | Human Prescription Drug |
| 61314-206 | Pilocarpine Hydrochloride | Pilocarpine Hydrochloride | Solution/ Drops | Ophthalmic | Sandoz Inc | Human Prescription Drug |
