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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 90553

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

Open FDA event record

Event summary

Timeline bucket
June 29, 2022
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Mckesson Medical-Surgical Inc. Corporate Office

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

Complete imported group

Every recalled product in this event

17 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 17

Triple Antibiotic Ointment, Bacitracin zinc, Neomycin sulfate, Polymixin B sulfate, First Aid Antibiotic, Triple Antibiotic Ointment, 144 packets per box, Net wt. per packet 0.5 g, Honeywell Safety Products, NDC 0498-0750-36.

D-1311-2022
Recall number
D-1311-2022
Initiated
June 29, 2022
Classification
Class II
Status
Terminated
Quantity
6 boxes

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: products were stored outside the drug label specifications.

Code information

Part# 231209G

Distribution pattern

Nationwide in the USA.

drug · product 2 of 17

Bisacodyl Suppositories, Fast Acting Stimulant Laxative, 100 suppositories per box, 10 mg each, Health Star, NDC 57896-443-01.

D-1312-2022
Recall number
D-1312-2022
Initiated
June 29, 2022
Classification
Class II
Status
Terminated
Quantity
45 boxes

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: products were stored outside the drug label specifications.

Code information

Part# 444-01-HST

Distribution pattern

Nationwide in the USA.

drug · product 3 of 17

Naphcon A eye drops, Naphazoline HCl 0.025% and Pheniramine Maleate 0.3%, Redness Reliever and Antihistamine Eye Drops, Sterile, 15 mL (0.5 FL OZ) bottle per box, Alcon, a Novartis company, NDC 0065-0085-15.

D-1313-2022
Recall number
D-1313-2022
Initiated
June 29, 2022
Classification
Class II
Status
Terminated
Quantity
12 boxes

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: products were stored outside the drug label specifications.

Code information

Part# 0065008515

Distribution pattern

Nationwide in the USA.

drug · product 4 of 17

Systane, Lubricant Eye Drops, Polyethylene Glycol 400 0.4% Lubricant, Propylene Glycol 0.3% Lubricant, Original, Long Lasting Dry Eye Relief, Sterile, a) 15 mL (0.5 FL OZ) NDC 0065-0429-15, b) 30 mL (1 FL OZ) NDC 0065-0429-30, bottle per box, Alcon Surgical Inc.

D-1314-2022
Recall number
D-1314-2022
Initiated
June 29, 2022
Classification
Class II
Status
Terminated
Quantity
47 bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: products were stored outside the drug label specifications.

Code information

Part# a) 0065042915, b) 0065042930

Distribution pattern

Nationwide in the USA.

drug · product 5 of 17

Eye-stream, eye wash solution, sterile, 4 FL OZ (118 mL) bottle per box, Alcon, NDC 0065-0530-04.

D-1315-2022
Recall number
D-1315-2022
Initiated
June 29, 2022
Classification
Class II
Status
Terminated
Quantity
16 boxes

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: products were stored outside the drug label specifications.

Code information

Part# 0065053004

Distribution pattern

Nationwide in the USA.

drug · product 6 of 17

Systane Balance, Lubricant Eye Drops, Propylene Glycol 0.6% lubricant, Restorative Formula, Sterile, 10 mL (1/3 FL OZ) bottle per box, Alcon, NDC 0065-1433-02.

D-1316-2022
Recall number
D-1316-2022
Initiated
June 29, 2022
Classification
Class II
Status
Terminated
Quantity
12 boxes

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: products were stored outside the drug label specifications.

Code information

Part# 0065143302

Distribution pattern

Nationwide in the USA.

drug · product 7 of 17

Systane Zaditor, ketotifen fumarate ophthalmic solution 0.035%, Antihistamine eye drops, Eye Itch Relief, up to 12 Hours, Sterile, 30 day supply, 5mL (0.17 FL OZ) bottle per box, Alcon, NDC 0065-4011-05.

D-1317-2022
Recall number
D-1317-2022
Initiated
June 29, 2022
Classification
Class II
Status
Terminated
Quantity
9 boxes

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: products were stored outside the drug label specifications.

Code information

Part# 0065401105

Distribution pattern

Nationwide in the USA.

drug · product 8 of 17

Debrox, Carbamide Peroxide, Earwax Removal Aid, 0.5 FL OZ (15 mL) bottle per box), MedTech Products Inc., NDC 63029-321-01.

D-1318-2022
Recall number
D-1318-2022
Initiated
June 29, 2022
Classification
Class II
Status
Terminated
Quantity
131 boxes

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: products were stored outside the drug label specifications.

Code information

Part# 04203710478

Distribution pattern

Nationwide in the USA.

drug · product 9 of 17

Miralax (Polyethylene Glycol 3350), Powder for Solution, Osmotic Laxative, 30 Once-Daily Doses, Net WT 17.9 OZ (510 g) bottle, Bayer Healthcare Pharmaceuticals, NDC 11523-7234-4.

D-1319-2022
Recall number
D-1319-2022
Initiated
June 29, 2022
Classification
Class II
Status
Terminated
Quantity
67 bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: products were stored outside the drug label specifications.

Code information

Part# 11523723404

Distribution pattern

Nationwide in the USA.

drug · product 10 of 17

GenTeal Tears, Lubricant Eye Ointment, Night-Time Ointment, Sterile, 3.5 gm (0.12 FL OZ) per box, Alcon, NDC 0065-0518-01.

D-1320-2022
Recall number
D-1320-2022
Initiated
June 29, 2022
Classification
Class II
Status
Terminated
Quantity
40 boxes

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: products were stored outside the drug label specifications.

Code information

Part# 30065051801

Distribution pattern

Nationwide in the USA.

drug · product 11 of 17

Pataday, Once Daily Relief, Olopatadine hydrochloride ophthalmic solution 0.2%, Antihistamine, Eye Allergy Itch Relief, Once Daily, Sterile, 2.5 mL (0.085 FL OZ) bottle per box, Alcon, NDC 0065-8150-01.

D-1321-2022
Recall number
D-1321-2022
Initiated
June 29, 2022
Classification
Class II
Status
Terminated
Quantity
1 box

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: products were stored outside the drug label specifications.

Code information

Part# 00065815001

Distribution pattern

Nationwide in the USA.

drug · product 12 of 17

A&D Original Ointment, Diaper Rash Ointment & Skin Protectant, 16 oz. Jar, Bayer Healthcare Pharmaceutica, NDC 11523-0096-3.

D-1322-2022
Recall number
D-1322-2022
Initiated
June 29, 2022
Classification
Class II
Status
Terminated
Quantity
1 Jar

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: products were stored outside the drug label specifications.

Code information

Unavailable

Distribution pattern

Nationwide in the USA.

drug · product 13 of 17

Dakin's Solution, a) sodium hypochlorite 0.125%, quarter strength, NDC 0436-0672-16, b) sodium hypochlorite 0.25%, half strength, NDC 0436-0936-16, c) sodium hypochlorite 0.5% full strength, NDC 0436-0946-16, Antimicrobial, 473 mL (16 fl oz) bottle, Century Pharmaceuticals, Inc.

D-1323-2022
Recall number
D-1323-2022
Initiated
June 29, 2022
Classification
Class II
Status
Terminated
Quantity
113 bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: products were stored outside the drug label specifications.

Code information

Unavailable

Distribution pattern

Nationwide in the USA.

drug · product 14 of 17

Asthmanefrin Racephinephrine Inhalation Solution Bronchodilator, For temporary relief of mild symptoms of intermittent asthma, Preservative Free, Sterile, For Oral Inhalation Only, 30 vials per box, Nephron Pharmaceuticals Corporation, NDC 0487-2784-01.

D-1324-2022
Recall number
D-1324-2022
Initiated
June 29, 2022
Classification
Class II
Status
Terminated
Quantity
1 box

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: products were stored outside the drug label specifications.

Code information

Unavailable

Distribution pattern

Nationwide in the USA.

drug · product 15 of 17

Racepinephrine Inhalation Solution, USP 2.25%, Bronchodilator, For Oral Inhalation Only, Sulfite Free, Preservative Free, 30 x 0.5 mL Sterile Unit-of-Use Vials, each in a foil pouch, per carton, Nephron Pharmaceuticals Corporation, NDC 0487-5901-99.

D-1325-2022
Recall number
D-1325-2022
Initiated
June 29, 2022
Classification
Class II
Status
Terminated
Quantity
23 cartons

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: products were stored outside the drug label specifications.

Code information

Unavailable

Distribution pattern

Nationwide in the USA.

drug · product 16 of 17

Sterile Alcohol Prep Pads, Sterile, Latex Free, 100 large pads per box, manufactured for: Dynarex Corporation, NY 10962, NDC 67777-121-16.

D-1326-2022
Recall number
D-1326-2022
Initiated
June 29, 2022
Classification
Class II
Status
Terminated
Quantity
10 boxes

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: products were stored outside the drug label specifications.

Code information

Part# 1116

Distribution pattern

Nationwide in the USA.

drug · product 17 of 17

Alcohol Swabsticks, Antiseptic, 50 4" saturated individual packets per box, Manufactured for: Dynarex Corporation, NY 10962, Made in Mexico, NDC 67777-300-01 (current NDC) NDC# 67777-120-10 (discontinued)

D-1327-2022
Recall number
D-1327-2022
Initiated
June 29, 2022
Classification
Class II
Status
Terminated
Quantity
Unavailable

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: products were stored outside the drug label specifications.

Code information

Part# 1203

Distribution pattern

Nationwide in the USA.