FDA (Drugs) recall action 83417

Medtech Products, Inc. recalled 14 products on 2019-08-28

The FDA (Drugs) publishes a recall like this one as 14 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 14 pages.

Products: 14
Announced: 2019-08-28
Critical: 0
Units: 13,478,502

Why these products were recalled

CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility that could impact the product quality of the finished products.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–14 of 14

ModerateFDA (Drugs)··2019-08-28
Medtech Recalls Clear Eyes Redness Relief Eye Drops for Quality Control Issues
Medtech Products is recalling Clear Eyes Redness Relief eye drops due to concerns about quality assurance controls in the manufacturing facility.
Product
Clear Eyes Redness Relief Club Pack Display; each display contains 18 3-Pack bottles (UPC 6 78112 10552 6) of Clear eyes REDNESS RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.12%) eye drops, 0.5 FL OZ (15 mL) bottle (individual bottle UPC 6 78112 25415 6); Distributed by…
Category
Distribution
1 state
ModerateFDA (Drugs)··2019-08-28
Medtech Recalls Clear Eyes Redness Relief Eye Drops for Quality Control Issues
Medtech Products, Inc. is recalling Clear Eyes Redness Relief eye drops due to concerns about quality assurance controls in the manufacturing facility.
Product
Clear Eyes Redness Relief Hand Pocket Pal Tray Display; each display (UPC 6 78112 25418 7) contains 48 each of Clear eyes REDNESS RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.012%) eye drops, 0.2 FL OZ (6 mL) bottle, Handy Pocket Pal (UPC 6 78112 25418 7); Distributed by…
Category
Distribution
1 state
ModerateFDA (Drugs)··2019-08-28
Medtech Recalls Clear Eyes Redness Relief Eye Drops for Quality Control Issues
Medtech Products is recalling Clear Eyes Redness Relief eye drops due to concerns about quality assurance controls in the manufacturing facility.
Product
Clear eyes REDNESS RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.012%) eye drops, Handy Pocket Pal, 0.2 FL OZ (6 mL) bottle, Dist. by Lil' Drug Store Products Inc., 1201 Continental Place NE, Cedar Rapids, IA 52402; Medtech Products Inc., Tarrytown, NY 10591, UPC 7 92554…
Category
Distribution
1 state
ModerateFDA (Drugs)··2019-08-28
Medtech Recalls Clear Eyes Eye Drops Due to Quality Control Concerns
Medtech Products is recalling Clear Eyes eye drops due to quality assurance concerns at the manufacturing facility. The recall covers 66,168 bottles distributed in the US, Puerto Rico, and several Caribbean nations.
Product
Clear Eyes Maximum Redness and Itchy Eye Relief Sidekick Display; each display contains 12 each of a) Clear eyes MAXIMUM REDNESS RELIEF (Glycerin 0.5%, Naphazoline hydrochloride 0.03%) eye drops, 0.5 FL OZ (15 mL) bottle, (UPC 6 78112 66577 8); and b) Clear eyes MAXIMUM ITCHY…
Category
Distribution
1 state
ModerateFDA (Drugs)··2019-08-28
Medtech Recalls Clear Eyes Maximum Redness Relief Eye Drops
Medtech Products is recalling Clear Eyes Maximum Redness Relief eye drops due to manufacturing quality control concerns.
Product
Clear Eyes Maximum Redness Relief Club Pack Display; each display contains 18 3-Pack bottles (UPC 6 78112 10859 6) of Clear eyes MAXIMUM REDNESS RELIEF (Glycerin 0.5%, Naphazoline hydrochloride 0.03%) eye drops, 0.5 FL OZ (15 mL) bottle, (UPC 6 78112 66577 8); Distributed by…
Category
Distribution
1 state
ModerateFDA (Drugs)··2019-08-28
Medtech Recalls Clear Eyes Itchy Eye Relief Due to Quality Control Issues
Medtech Products is recalling 1,752 bottles of Clear Eyes Maximum Itchy Eye Relief due to concerns about quality assurance controls in the manufacturing facility.
Product
Clear Eyes Maximum Itchy Eye Relief Sidekick Floor Stand Display; each display contains 12 each of Clear eyes MAXIMUM ITCHY EYE RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.012%, Zinc Sulfate 0.25%) eye drops, 0.5 FL OZ (15 mL) bottle, (UPC 6 78112 65920 30; Distributed…
Category
Distribution
1 state
ModerateFDA (Drugs)··2019-08-28
Medtech Recalls Clear Eyes Redness Relief Eye Drops for Quality Control Issues
Medtech Products is recalling Clear Eyes Redness Relief eye drops due to concerns about quality assurance controls at the manufacturing facility.
Product
Clear Eyes Redness Relief Handy Pocket Pal Club Pak Display; each display (case UPC 30300742541283) contains 48 each of Clear eyes REDNESS RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.012%) eye drops, 0.2 FL OZ (6 mL) bottle, Handy Pocket Pal (UPC 6 78112 25418 7)…
Category
Distribution
1 state
ModerateFDA (Drugs)··2019-08-28
Medtech Recalls Clear Eyes Maximum Itchy Eye Relief Due to Quality Concerns
Medtech Products is recalling 1,836 bottles of Clear Eyes Maximum Itchy Eye Relief due to concerns about quality assurance controls in the manufacturing facility.
Product
Clear Eyes Maximum Itchy Eye Relief Sidekick Floor Stand Display; each display (case UPC 10678112736383) contains 12 each of Clear eyes MAXIMUM ITCHY EYE RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.012%, Zinc Sulfate 0.25%) eye drops, 0.5 FL OZ (15 mL) bottle, (UPC 6…
Category
Distribution
1 state
ModerateFDA (Drugs)··2019-08-28
Medtech Recalls Clear Eyes Maximum Redness Relief Eye Drops
Medtech Products is recalling Clear Eyes Maximum Redness Relief eye drops due to quality assurance concerns at the manufacturing facility.
Product
Clear eyes MAXIMUM REDNESS RELIEF (Glycerin 0.5%, Naphazoline hydrochloride 0.03%) eye drops, 0.5 FL OZ (15 mL) bottle, Distributed by Medtech Products Inc., Tarrytown, NY 10591, A Prestige Brands Company, UPC 6 78112 66577 8.
Category
Distribution
1 state
ModerateFDA (Drugs)··2019-08-28
Medtech Recalls Clear Eyes Redness Relief Eye Drops for Quality Concerns
Medtech Products is recalling Clear Eyes Redness Relief eye drops due to quality assurance concerns at the manufacturing facility.
Product
Clear eyes REDNESS RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.012%) eye drops, Handy Pocket Pal, 0.2 FL OZ (6 mL) bottle, Distributed by Select Corporation, Carrolton, TX 75007; Medtech Products Inc., Tarrytown, NY 10591, A Prestige Brands Company, UPC 6 55708 01039…
Category
Distribution
1 state
ModerateFDA (Drugs)··2019-08-28
Medtech Recalls Clear Eyes Eye Drops Due to Quality Assurance Concerns
Medtech Products, Inc. is recalling Clear Eyes eye drops due to concerns about quality assurance controls in the manufacturing facility.
Product
Clear Eyes Assorted Sidekick Floor Stand Display; each display contains 6 each of a) Clear eyes REDNESS RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.12%) eye drops, 0.5 FL OZ (15 mL) bottle (UPC 6 78112 25415 6); b) Clear eyes MAXIMUM REDNESS RELIEF (Glycerin 0.5%…
Category
Distribution
1 state
ModerateFDA (Drugs)··2019-08-28
Medtech Recalls Clear Eyes Redness Relief Eye Drops for Quality Control Issues
Medtech Products, Inc. is recalling Clear Eyes Redness Relief eye drops due to concerns about quality assurance controls at the manufacturing facility.
Product
Clear eyes REDNESS RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.012%) eye drops, packaged in a) 0.5 FL OZ (15 mL) bottle (UPC 6 78112 25415 6); b) 1 FL OZ (30 mL) bottle (UPC 6 78112 25419 4); c) 0.2 FL OZ (6 mL) bottle, Handy Pocket Pal (UPC 6 78112 25418 7); Distributed…
Category
Distribution
1 state
ModerateFDA (Drugs)··2019-08-28
Medtech Recalls Clear Eyes Maximum Itchy Eye Relief Drops
Medtech Products is recalling Clear Eyes Maximum Itchy Eye Relief drops due to quality assurance concerns at the manufacturing facility.
Product
Clear eyes MAXIMUM ITCHY EYE RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.012%, Zinc Sulfate 0.25%) eye drops, 0.5 FL OZ (15 mL) bottle, Distributed by Medtech Products Inc., Tarrytown, NY 10591, A Prestige Brands Company, UPC 6 78112 65920 3.
Category
Distribution
1 state
ModerateFDA (Drugs)··2019-08-28
Medtech Recalls Clear Eyes Assorted Displays Due to Quality Control Concerns
Medtech Products is recalling Clear Eyes Assorted IRC Displays due to concerns about quality assurance controls in the manufacturing facility.
Product
Clear Eyes Assorted IRC Display; each display contains 6 each of a) Clear eyes REDNESS RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.12%) eye drops, 0.5 FL OZ (15 mL) bottle (UPC 6 78112 25415 6); b) Clear eyes MAXIMUM REDNESS RELIEF (Glycerin 0.5%, Naphazoline…
Category
Distribution
1 state