Class II · Moderate risk
Pilocarpine Hydrochloride Ophthalmic Solution
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Pilocarpine Hydrochloride Ophthalmic Solution 4%
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Failed Impurities/Degradation Specifications.
Cause type: Impurity / degradation
An impurity or degradation product above its limit - other than nitrosamines. Unexpected substances in a batch can make it unsafe or less effective, even when the active ingredient is present. All impurity / degradation recalls.
What was recalled
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
Affected NDC
61314-0206-15
Compare with the code on your package — it is the most precise check available.
Drug: Pilocarpine Category: Eye Drops & Ophthalmic
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Pilocarpine Hydrochloride NDC 61314-0206 |
40 mg/mL | Solution/ Drops Ophthalmic |
Sandoz Inc | Rx |
- Recalling firm
- Novartis Pharmaceuticals Corp.
- NDC code
- 61314-206-15
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0679-2017 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Pilocarpine recalls
See all
Class II · Moderate risk
Pilocarpine Hydrochloride Ophthalmic Solution
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk
Pilocarpine Hydrochloride Ophthalmic Solution
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk
Pilocarpine HCL Ophthalmic Solution
cGMP deviations: Temperature abuse
Class III · Low risk
Isopto Carpine
Failed Impurities/Degradation Specifications.
Other recalls by Novartis Pharmaceuticals Corp.
All 2017 recalls
Class II · Moderate risk
Diovan (valsartan)
Failed Dissolution Specifications
Class I · High risk
SANDIMMUNE Oral Solution
Crystallization: bottles of Sandimmune Oral Solution were determined to contain crystals
Class I · High risk
SANDIMMUNE Oral Solution
Crystallization: bottles of Sandimmune Oral Solution were determined to contain crystals.
Class II · Moderate risk
Neoral soft gelatin capsules
CGMP deviations: Out of specification results obtained during routine stability testing for ethanol content.
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