Class II · Moderate risk
GenTeal Tears
Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.
National Drug Code
Is NDC 0065-8064-01 recalled?
GenTeal Tears Severe · 1 TUBE in 1 CARTON (0065-8064-01) / 10 g in 1 TUBE
Yes — this exact package was recalled
1 FDA recall names the code 0065-8064-01 directly. A recall still applies to particular lot numbers — compare the lot on your package with the FDA notice below, and talk to your pharmacist before stopping a prescribed medication.
1 of these recalls is still ongoing.
- Active ingredient
- Hypromellose
- Strength
- HYPROMELLOSE 2910 (4000 MPA.S) .003 g/g
- Form
- Gel · Ophthalmic
- Labeler
- Alcon Laboratories, Inc.
- Type
- Human OTC Drug
- Product code
- 0065-8064
Recalls naming this package
Where to find this code. The NDC is printed on the pharmacy label and on the manufacturer's carton, usually as three groups of digits after “NDC”. The last group is the package size — two bottles of the same medicine can differ only in that group, and a recall may cover one but not the other.
Other recalled products from this labeler
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