Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Lack of Assurance of Sterility
Cause type: Sterility / contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.
Artificial Tears Lubricant Eye Drops (glycerin 0.2%, hypromellose 0.2%, polyethylene glycol 400 1%), 0.5 oz bottles, Mfg: Geri-Care; Brooklyn, New York NDC 68788-7266-0
Compare with the code on your package — it is the most precise check available.
Category: Eye Drops & Ophthalmic
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 |
|---|---|---|---|---|
| Artificial Tears Glycerin NDC 68788-7266 |
.002 mg/mg; HYPROMELLOSE, UNSPECIFIED .002 mg/mg; POLYETHYLENE GLYCOL 400 .01 mg/mg | Solution/ Drops Ophthalmic |
Preferred Pharmaceuticals Inc. | OTC |
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall.
Defective container: Preferred Pharmaceuticals received a letter from the manufacturer Glenmark, that the blister packs are not fully sealed and tablets falling out. Preferred Pharmaceuticals purchased the finished product and repackaged the product for sale.
cGMP Deviations
Failed Impurities/Degradation Specifications - at 18-month Stability testing
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
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