Exact FDA event identifier

Event 83417

14 recalled-product records grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: July 26, 2019
Product types: Drug
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Medtech Products, Inc.

Dossier provenance

Source snapshots represented here

openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Device root-cause evidence is not applicable to this event. No grouped product has the official product type device; this is not an unavailable-enrichment finding.

Complete imported group

Every recalled product in this event

14 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 14

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 by Medtech Products Inc., Tarrytown, NY 10591; A Prestige Brands Company.

D-1822-2019

Recall number: D-1822-2019
Initiated: July 26, 2019
Classification: Class II
Status: Terminated
Recalling firm: Medtech Products, Inc.
Quantity: 6,661,188 bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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.

Code information

Lot #: a) 16195, Exp 07/19; 16211, 16216, Exp 08/19; b) 16205, Exp 07/19; 16211, Exp 08/19; c) 16192, 16203, Exp 07/19; 16242, Exp 09/19; 16280, 16285, Exp 10/19; 16300, Exp 11/19; 16336, Exp 12/19; 17002, 17012, Exp 01/20; 17051, Exp 02/20; 17130, Exp 04/20; 17147, Exp 05/20

Distribution pattern

Nationwide in the USA and Puerto Rico, St. Michael, Barbados, Guyana, St. Johns, Antigua and Barbuda, Kingston 5, and Jamaica.

drug · product 2 of 14

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 70103 7.

D-1823-2019

Recall number: D-1823-2019
Initiated: July 26, 2019
Classification: Class II
Status: Terminated
Recalling firm: Medtech Products, Inc.
Quantity: 1,621,200 bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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.

Code information

Lot #: 16321, Exp 11/19; 16336, Exp 12/19; 17012, Exp 01/20; 17034, 17051, Exp 02/20; 17147, Exp 05/20

Distribution pattern

Nationwide in the USA and Puerto Rico, St. Michael, Barbados, Guyana, St. Johns, Antigua and Barbuda, Kingston 5, and Jamaica.

drug · product 3 of 14

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.

D-1824-2019

Recall number: D-1824-2019
Initiated: July 26, 2019
Classification: Class II
Status: Terminated
Recalling firm: Medtech Products, Inc.
Quantity: 927,108 bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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.

Code information

Lot #: 16302, Exp 11/19; 16331, 16344, Exp 12/19; 17011, 17016, Exp 01/20.

Distribution pattern

Nationwide in the USA and Puerto Rico, St. Michael, Barbados, Guyana, St. Johns, Antigua and Barbuda, Kingston 5, and Jamaica.

drug · product 4 of 14

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.

D-1825-2019

Recall number: D-1825-2019
Initiated: July 26, 2019
Classification: Class II
Status: Terminated
Recalling firm: Medtech Products, Inc.
Quantity: 1,872,984 bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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.

Code information

Lot #: 16234, 16247, Exp 08/19; 16286, Exp 10/19; 16314, Exp 11/19

Distribution pattern

Nationwide in the USA and Puerto Rico, St. Michael, Barbados, Guyana, St. Johns, Antigua and Barbuda, Kingston 5, and Jamaica.

drug · product 5 of 14

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 hydrochloride 0.03%), 0.5 FL OZ (15 mL) bottle (UPC 6 78112 66577 8); and c) Clear eyes MAXIMUM ITCHY EYE RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.012%, Zinc Sulfate 0.25%), 0.5 FL OZ (15 mL) bottle (UPC 6 78112 65920 3); Distributed by Medtech Products Inc., Tarrytown, NY 10591, A Prestige Brands Company, display UPC 6 78112 10452 9.

D-1826-2019

Recall number: D-1826-2019
Initiated: July 26, 2019
Classification: Class II
Status: Terminated
Recalling firm: Medtech Products, Inc.
Quantity: 20,808 bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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.

Code information

Lot #: Display 17E23A, Exp 12/19; lot and expiry for individual products within this display are captured in each individual product Code Information

Distribution pattern

Nationwide in the USA and Puerto Rico, St. Michael, Barbados, Guyana, St. Johns, Antigua and Barbuda, Kingston 5, and Jamaica.

drug · product 6 of 14

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 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 3); Distributed by Medtech Products Inc., Tarrytown, NY 10591, A Prestige Brands Company, case UPC 00678112105434.

D-1827-2019

Recall number: D-1827-2019
Initiated: July 26, 2019
Classification: Class II
Status: Terminated
Recalling firm: Medtech Products, Inc.
Quantity: 66,168 bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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.

Code information

Lot #: Display 17C30A, Exp 10/19; lot and expiry for individual products within this display are captured in each individual product Code Information

Distribution pattern

Nationwide in the USA and Puerto Rico, St. Michael, Barbados, Guyana, St. Johns, Antigua and Barbuda, Kingston 5, and Jamaica.

drug · product 7 of 14

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%, Naphazoline hydrochloride 0.03%), 0.5 FL OZ (15 mL) bottle (UPC 6 78112 66577 8); and c) Clear eyes MAXIMUM ITCHY EYE RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.012%, Zinc Sulfate 0.25%), 0.5 FL OZ (15 mL) bottle (UPC 6 78112 65920 3); Distributed by Medtech Products Inc., Tarrytown, NY 10591, A Prestige Brands Company, case UPC 00678112106905.

D-1828-2019

Recall number: D-1828-2019
Initiated: July 26, 2019
Classification: Class II
Status: Terminated
Recalling firm: Medtech Products, Inc.
Quantity: 25,992 bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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.

Code information

Lot #: Display 17E12A, Exp 09/19; lot and expiry for individual products within this display are captured in each individual product Code Information

Distribution pattern

Nationwide in the USA and Puerto Rico, St. Michael, Barbados, Guyana, St. Johns, Antigua and Barbuda, Kingston 5, and Jamaica.

drug · product 8 of 14

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 Medtech Products Inc., Tarrytown, NY 10591, A Prestige Brands Company.

D-1829-2019

Recall number: D-1829-2019
Initiated: July 26, 2019
Classification: Class II
Status: Terminated
Recalling firm: Medtech Products, Inc.
Quantity: 124,038 bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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.

Code information

Lot #: 3-pack Q16299D2, Exp 07/19; Q162300D1, Q16260B1, Q16261B1, Q16263B1, Q16301D1, Q16302D1, Q16303D1, Q16308D1, Q16309D1, Q16336D1, Q16337D1, Q16340D1, Q16342D1, Q16343D1, Q16344D1, Exp 08/19; lot and expiry for individual products within this display are captured in each individual product Code Information

Distribution pattern

Nationwide in the USA and Puerto Rico, St. Michael, Barbados, Guyana, St. Johns, Antigua and Barbuda, Kingston 5, and Jamaica.

drug · product 9 of 14

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 by Medtech Products Inc., Tarrytown, NY 10591, A Prestige Brands Company, case UPC 10678112106995.

D-1830-2019

Recall number: D-1830-2019
Initiated: July 26, 2019
Classification: Class II
Status: Terminated
Recalling firm: Medtech Products, Inc.
Quantity: 1,752 bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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.

Code information

Lot #: 16331, 16344, EXP 12/19

Distribution pattern

Nationwide in the USA and Puerto Rico, St. Michael, Barbados, Guyana, St. Johns, Antigua and Barbuda, Kingston 5, and Jamaica.

drug · product 10 of 14

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 Medtech Products Inc., Tarrytown, NY 10591, A Prestige Brands Company.

D-1831-2019

Recall number: D-1831-2019
Initiated: July 26, 2019
Classification: Class II
Status: Terminated
Recalling firm: Medtech Products, Inc.
Quantity: 17,316 bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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.

Code information

Lot #: Q16322M1, Q16323M1, Q16323M2, Q16326M1, Exp 08/19; lot and expiry for individual products within this display are captured in each individual product Code Information

Distribution pattern

Nationwide in the USA and Puerto Rico, St. Michael, Barbados, Guyana, St. Johns, Antigua and Barbuda, Kingston 5, and Jamaica.

drug · product 11 of 14

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 78112 65920 3), Distributed by Medtech Products Inc., Tarrytown, NY 10591, A Prestige Brands Company.

D-1832-2019

Recall number: D-1832-2019
Initiated: July 26, 2019
Classification: Class II
Status: Terminated
Recalling firm: Medtech Products, Inc.
Quantity: 1,836 bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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.

Code information

Lot #: 16331, 16344, Exp 12/19

Distribution pattern

Nationwide in the USA and Puerto Rico, St. Michael, Barbados, Guyana, St. Johns, Antigua and Barbuda, Kingston 5, and Jamaica.

drug · product 12 of 14

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); Distributed by Medtech Products Inc., Tarrytown, NY 10591; A Prestige Brands Company.

D-1833-2019

Recall number: D-1833-2019
Initiated: July 26, 2019
Classification: Class II
Status: Terminated
Recalling firm: Medtech Products, Inc.
Quantity: 793,872 bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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.

Code information

Lot # 16242, Exp 09/19; 16280, Exp 10/19; 17051, Exp 02/20; 17130, Exp 04/20

Distribution pattern

Nationwide in the USA and Puerto Rico, St. Michael, Barbados, Guyana, St. Johns, Antigua and Barbuda, Kingston 5, and Jamaica.

drug · product 13 of 14

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 6.

D-1834-2019

Recall number: D-1834-2019
Initiated: July 26, 2019
Classification: Class II
Status: Terminated
Recalling firm: Medtech Products, Inc.
Quantity: 1,030,128 bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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.

Code information

Lot #: 16192, 16203, Exp 07/19; 16321, Exp 11/19; 17002, Exp 01/20; 17034, Exp 02/20

Distribution pattern

Nationwide in the USA and Puerto Rico, St. Michael, Barbados, Guyana, St. Johns, Antigua and Barbuda, Kingston 5, and Jamaica.

drug · product 14 of 14

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 Medtech Products Inc., Tarrytown, NY 10591 A Prestige Brands Company.

D-1835-2019

Recall number: D-1835-2019
Initiated: July 26, 2019
Classification: Class II
Status: Terminated
Recalling firm: Medtech Products, Inc.
Quantity: 314,112 bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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.

Code information

Lot #: 17051, Exp 02/20; 17130, Exp 04/20; 17147, Exp 05/20

Distribution pattern

Nationwide in the USA and Puerto Rico, St. Michael, Barbados, Guyana, St. Johns, Antigua and Barbuda, Kingston 5, and Jamaica.