FDA Drug recall D-0679-2017
Pilocarpine Hydrochloride Ophthalmic Solution 4% , packaged in 15 mL bottles, Rx Only, Manufactured by Alcon Laboratories, Inc
- FDA Drug
- Class III
- terminated
- Published 2017-05-03
On 2017-05-03 the FDA classified a Class III recall of Pilocarpine Hydrochloride Ophthalmic Solution 4% , packaged in 15 mL bottles, Rx Only, Manufactured by Alcon Laboratories, Inc by Novartis Pharmaceuticals, citing failed Impurities/Degradation Specifications.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0679-2017 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2017-03-22 |
| Published | 2017-05-03 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Novartis Pharmaceuticals |
| Distribution | US |
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
Reason
Failed Impurities/Degradation Specifications.
Identifiers
| ndc | 61314-203-15 |
|---|---|
| ndc | 61314-204-15 |
| ndc | 61314-206-15 |
| code_info | Lot #: 244660F, Exp. FEB 2018 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0679-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.