Why it was recalled
Failed Impurities/Degradation Specifications.
Product description
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
Lot numbers, UPCs & expiration codes
Lot #: 244660F, Exp. FEB 2018
Where it was sold
nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0679-2017
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Mar 22, 2017
- FDA report date
- May 3, 2017
- Quantity
- N/A
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Novartis Pharmaceuticals Corp.
Original FDA data
Every field from FDA enforcement report D-0679-2017, exactly as published.
Show all FDA fields
- City
- East Hanover
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 76756
- Address
- 1 Health Plz
- Code information
- Lot #: 244660F, Exp. FEB 2018
- Postal code
- 07936-1016
- Report date
- May 3, 2017
- Product type
- Drugs
- Recall number
- D-0679-2017
- Classification
- Class III
- Recalling firm
- Novartis Pharmaceuticals Corp.
- Termination date
- Feb 5, 2020
- Reason for recall
- Failed Impurities/Degradation Specifications.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- nationwide
- Recall initiation date
- Mar 22, 2017
- Initial firm notification
- Letter
- Center classification date
- Apr 21, 2017