Drug recall: Triple Antibiotic Ointment, Bacitracin zinc, Neomycin sulfate, Polymixin B sulfate, First Aid Antibiotic, Triple…

Class II FDA enforcement event 90553. Recall start date: 29 Jun 2022. Status in the FDA record: Terminated. Termination date: 13 Feb 2024.

Reason for recall, in the words of FDA

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

Class II, in the words of FDA

a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote

Mckesson Medical-Surgical Inc. Corporate Office started this drug recall on 29 Jun 2022. The firm address in the FDA record is in Richmond, VA. FDA put the recall in Class II. FDA event 90553 has 17 product records. The first FDA enforcement report date is 17 Aug 2022. The record gives the status Terminated, with the termination date 13 Feb 2024.

FDA enforcement report The 17 product records

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

Nationwide in the USA.

Recalling firm

Mckesson Medical-Surgical Inc. Corporate Office, Richmond, VA.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

17 product records in the event.

FDA event 90553: product records
Recall number	Product	Quantity	Class	Status	Report date
D-1311-2022	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.	6 boxes	Class II	Terminated	17 Aug 2022
D-1312-2022	Bisacodyl Suppositories, Fast Acting Stimulant Laxative, 100 suppositories per box, 10 mg each, Health Star, NDC 57896-443-01.	45 boxes	Class II	Terminated	17 Aug 2022
D-1313-2022	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.	12 boxes	Class II	Terminated	17 Aug 2022
D-1314-2022	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.	47 bottles	Class II	Terminated	17 Aug 2022
D-1315-2022	Eye-stream, eye wash solution, sterile, 4 FL OZ (118 mL) bottle per box, Alcon, NDC 0065-0530-04.	16 boxes	Class II	Terminated	17 Aug 2022
D-1316-2022	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.	12 boxes	Class II	Terminated	17 Aug 2022
D-1317-2022	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.	9 boxes	Class II	Terminated	17 Aug 2022
D-1318-2022	Debrox, Carbamide Peroxide, Earwax Removal Aid, 0.5 FL OZ (15 mL) bottle per box), MedTech Products Inc., NDC 63029-321-01.	131 boxes	Class II	Terminated	17 Aug 2022
D-1319-2022	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.	67 bottles	Class II	Terminated	17 Aug 2022
D-1320-2022	GenTeal Tears, Lubricant Eye Ointment, Night-Time Ointment, Sterile, 3.5 gm (0.12 FL OZ) per box, Alcon, NDC 0065-0518-01.	40 boxes	Class II	Terminated	17 Aug 2022
D-1321-2022	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.	1 box	Class II	Terminated	17 Aug 2022
D-1322-2022	A&D Original Ointment, Diaper Rash Ointment & Skin Protectant, 16 oz. Jar, Bayer Healthcare Pharmaceutica, NDC 11523-0096-3.	1 Jar	Class II	Terminated	17 Aug 2022
D-1323-2022	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.	113 bottles	Class II	Terminated	17 Aug 2022
D-1324-2022	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.	1 box	Class II	Terminated	17 Aug 2022
D-1325-2022	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.	23 cartons	Class II	Terminated	17 Aug 2022
D-1326-2022	Sterile Alcohol Prep Pads, Sterile, Latex Free, 100 large pads per box, manufactured for: Dynarex Corporation, NY 10962, NDC 67777-121-16.	10 boxes	Class II	Terminated	17 Aug 2022
D-1327-2022	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)		Class II	Terminated	17 Aug 2022

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Drug events that started in 2022: 325
Share of these events in Class II: 65%
Product records in this event: 17Median of the firm: 3
Events of the firm on the register: 15

Other events of the firm

Other FDA enforcement events of Mckesson Medical-Surgical Inc. Corporate Office
Initiated	Product (first record)	Type	Class	Records
30 Jul 2025	Clearview Strep A Exact II Dipstick Respiratory Kit, CLIA Waived. Catalog Number: 4581225020	Device	Class II	1
25 Apr 2025	Medroxyprogesterone Acetate Injectable Suspension, USP, 150 mg / mL, 1 mL Single-Dose Vial, Rx only, Mfd. in India for:	Drug	Class II	2
24 Apr 2025	ABBOTT RAPID DX N AMERICA LLC MULTI ANALYTE LVL1&2250UL CHOLS CONTROL	Device	Class II	32
21 Apr 2025	PROLIA (denosumab), injection, 60mg/mL, For Subcutaneous Use Only, Rx Only, Manufactured by: Amgen Inc., Thousand Oaks,	Drug	Class II	3
17 Sep 2024	Quantimetrix Urine Chemistry Control Set Dipper Urinalysis Dipstick Testing Levels 1 & 2 6 X 15 mL-IVD intended as a con	Device	Class II	1
11 Sep 2024	Hylenex recombinant (hyaluronidase) injection, 150 USP units/mL, 4x1 mL Single Dose Vials, Rx only, Manufactured for and	Drug	Class II	1
11 Sep 2024	Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5% (sterile), 15 mL bottle, Rx only, MFG: Bausch & Lomb, NDC 24208	Drug	Class II	1
23 Apr 2024	Coviden Monoject 60ml Syringe Luer-Lock Tip-used to inject fluid into or withdraw fluids from the body MMS Catalog Numbe	Device	Class II	1
7 Feb 2024	Rocuronium Bromide Injection, Preservative Free, 10 mg / mL, Multiple-Dose Vial 10 mL, Rx only, Mfg: Auromedics Pharma L	Drug	Class II	3
9 Jan 2024	Sekisui Diagnostics Control Kit OSOM BVBLUE Bacterial Vaginosis	Device	Class II	5

Mckesson Medical-Surgical Inc. Corporate Office: all 15 events

Official channels

FDA enforcement report D-1311-2022The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

Follow by RSS:Food, drug and device recallsFDA Class I recalls

Cite this page

Recall Register. FDA enforcement event 90553. https://recallregister.com/fda/ii/90553/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA drug enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: Nationwide in the USA.
What quantity of product is in FDA event 90553?: The event has 17 product records. The first record gives this quantity: 6 boxes
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many drug recalls of 2022 have the same class?: 65% of the 325 drug events that started in 2022 are in Class II.