FDA Drug recall D-0678-2017
Isopto Carpine (pilocarpine hydrochloride opthalmic solution) 4%, packaged in 15 mL bottle, Rx only, Manufactured by: Alcon Laboratories, I…
- FDA Drug
- Class III
- terminated
- Published 2017-05-03
On 2017-05-03 the FDA classified a Class III recall of Isopto Carpine (pilocarpine hydrochloride opthalmic solution) 4%, packaged in 15 mL bottle, Rx only, Manufactured by: Alcon Laboratories, I… by Novartis Pharmaceuticals, citing failed Impurities/Degradation Specifications.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0678-2017 |
| 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
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
Reason
Failed Impurities/Degradation Specifications.
Identifiers
| code_info | Lot #: 244661F, 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.
Other recalls by Novartis Pharmaceuticals
- Diovan (valsartan) 160 mg, 90 tablets, Rx only, Manufactured by: Patheon Manufacturing Services LLC, Greenville, NC 27834, Distributed by:…
FDA Drug · Class II · 2026-08-19 · Novartis Pharmaceuticals - SANDIMMUNE Oral Solution (cyclosporine oral solution, USP) 100 mg/mL, 50 mL bottle, Rx Only, Manufactured by: DELPHARM Huningue S.A.S., Hun…
FDA Drug · Class I · 2023-12-13 · Novartis Pharmaceuticals - SANDIMMUNE Oral Solution (cyclosporine oral solution, USP) 100 mg/mL, 50 mL bottle, Rx Only, Manufactured by: DELPHARM Huningue S.A.S., Hun…
FDA Drug · Class I · 2023-09-27 · Novartis Pharmaceuticals - Neoral soft gelatin capsules (cyclosporine capsules, USP) Modified, 25 mg, Rx Only, 30 Soft Gelatin Capsules per carton, Mfg by: Novartis P…
FDA Drug · Class II · 2022-10-05 · Novartis Pharmaceuticals - Xiidra (lifitegrast ophthalmic solution) 5%, packaged in a) 60 Single-Use Containers: 12 pouches x 5 single-use containers (0.2 mL each via…
FDA Drug · Class III · 2022-06-15 · Novartis Pharmaceuticals
All Novartis Pharmaceuticals recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0678-2017%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.