Class II · Moderate risk
Dry Eye Relief Lubricant Eye Drops
CGMP Deviations: good manufacturing deficiencies related to a lack of documentation of the fill line.
National Drug Code
Is NDC 49348-0037-29 recalled?
Sunmark Eye Drops Original Formula · 1 BOTTLE, PLASTIC in 1 CARTON (49348-037-29) / 15 mL in 1 BOTTLE, PLASTIC
Yes — this exact package was recalled
3 FDA recalls name the code 49348-0037-29 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.
2 of these recalls are still ongoing.
- Active ingredient
- Tetrahydrozoline HCl
- Strength
- TETRAHYDROZOLINE HYDROCHLORIDE .05 g/100mL
- Form
- Solution/ Drops · Ophthalmic
- Labeler
- Strategic Sourcing Services LLC
- Type
- Human OTC Drug
- Product code
- 49348-0037
Recalls naming this package
Class II · Moderate risk
Original Eye Drops
CGMP Deviations: good manufacturing deficiencies related to a lack of documentation of the fill line.
Class III · Low risk
Eye Drops (Tetrahydrozoline HCl 0.05%)
CGMP Deviations: Active Pharmaceutical Ingredient (API) used for manufacture was stored in a non-GMP compliant warehouse at S.I.M.S., Italy.
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
- 49348-0109 See recall 2
- 49348-0136 See recall 2
- 49348-0001 See recall 1
- 49348-0410 See recall 1
- 49348-0543 Loratadine and Pseudoephedrine Sulfate 1
- 49348-0697 Sunmark Eye Drops Advanced Moisturizer/Lubricant 1
Free recall alerts
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