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

FDA recall notice · announced May 3, 2017 · Novartis Pharmaceuticals

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The 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 for recall

Failed Impurities/Degradation Specifications.

Notes

Distribution: nationwide
Lot/code information: Lot #: 244661F, Exp. Feb 2018
Quantity: N/A
Status: Terminated
Products in this recall event:
- 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 (D-0679-2017)
- 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 (D-0678-2017)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.