Recalls / Class III
Class IIID-0679-2017
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
- Brand name
- Pilocarpine Hydrochloride
- Generic name
- Pilocarpine Hydrochloride
- Active ingredient
- Pilocarpine Hydrochloride
- Route
- Ophthalmic
- NDCs
- 61314-203, 61314-204, 61314-206
- FDA application
- NDA200890
- Affected lot / code info
- Lot #: 244660F, Exp. FEB 2018
Why it was recalled
Failed Impurities/Degradation Specifications.
Recalling firm
- Firm
- Novartis Pharmaceuticals Corp.
- Manufacturer
- Sandoz Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1 Health Plz, N/A, East Hanover, New Jersey 07936-1016
Distribution
- Quantity
- N/A
- Distribution pattern
- nationwide
Timeline
- Recall initiated
- 2017-03-22
- FDA classified
- 2017-04-21
- Posted by FDA
- 2017-05-03
- Terminated
- 2020-02-05
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0679-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.