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- Recall Enforcement Event ID: 90553
Recall Enforment Report D-1320-2022
Recall Details
Multi event Drug Recall Enforcement Report Class II voluntary initiated by Mckesson Medical-Surgical Inc. Corporate Office, originally initiated on 06-29-2022 for the product GenTeal Tears, Lubricant Eye Ointment, Night-Time Ointment, Sterile, 3.5 gm (0.12 FL OZ) per box, Alcon, NDC 0065-0518-01. The product was recalled due to cgmp deviations: products were stored outside the drug label specifications.. The product was distributed nationwide and the recall is currently terminated.
Recall Enforcement Reports
| Recall Number | Recall Initiation Date | Report Date | Recall Classification | Quantity | Product Description | Recall Reason | Status |
|---|---|---|---|---|---|---|---|
| D-1320-2022 | 06-29-2022 | 08-17-2022 | Class II | 40 boxes | GenTeal Tears, Lubricant Eye Ointment, Night-Time Ointment, Sterile, 3.5 gm (0.12 FL OZ) per box, Alcon, NDC 0065-0518-01. | CGMP Deviations: products were stored outside the drug label specifications. | Terminated |
| D-1327-2022 | 06-29-2022 | 08-17-2022 | Class II | 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) | CGMP Deviations: products were stored outside the drug label specifications. | Terminated | |
| D-1323-2022 | 06-29-2022 | 08-17-2022 | Class II | 113 bottles | 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. | CGMP Deviations: products were stored outside the drug label specifications. | Terminated |
| D-1315-2022 | 06-29-2022 | 08-17-2022 | Class II | 16 boxes | Eye-stream, eye wash solution, sterile, 4 FL OZ (118 mL) bottle per box, Alcon, NDC 0065-0530-04. | CGMP Deviations: products were stored outside the drug label specifications. | Terminated |
| D-1316-2022 | 06-29-2022 | 08-17-2022 | Class II | 12 boxes | 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. | CGMP Deviations: products were stored outside the drug label specifications. | Terminated |
| D-1312-2022 | 06-29-2022 | 08-17-2022 | Class II | 45 boxes | Bisacodyl Suppositories, Fast Acting Stimulant Laxative, 100 suppositories per box, 10 mg each, Health Star, NDC 57896-443-01. | CGMP Deviations: products were stored outside the drug label specifications. | Terminated |
| D-1317-2022 | 06-29-2022 | 08-17-2022 | Class II | 9 boxes | 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. | CGMP Deviations: products were stored outside the drug label specifications. | Terminated |
| D-1314-2022 | 06-29-2022 | 08-17-2022 | Class II | 47 bottles | 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. | CGMP Deviations: products were stored outside the drug label specifications. | Terminated |
| D-1321-2022 | 06-29-2022 | 08-17-2022 | Class II | 1 box | 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. | CGMP Deviations: products were stored outside the drug label specifications. | Terminated |
| D-1313-2022 | 06-29-2022 | 08-17-2022 | Class II | 12 boxes | 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. | CGMP Deviations: products were stored outside the drug label specifications. | Terminated |
| D-1311-2022 | 06-29-2022 | 08-17-2022 | Class II | 6 boxes | 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. | CGMP Deviations: products were stored outside the drug label specifications. | Terminated |
| D-1322-2022 | 06-29-2022 | 08-17-2022 | Class II | 1 Jar | A&D Original Ointment, Diaper Rash Ointment & Skin Protectant, 16 oz. Jar, Bayer Healthcare Pharmaceutica, NDC 11523-0096-3. | CGMP Deviations: products were stored outside the drug label specifications. | Terminated |
| D-1325-2022 | 06-29-2022 | 08-17-2022 | Class II | 23 cartons | 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. | CGMP Deviations: products were stored outside the drug label specifications. | Terminated |
| D-1318-2022 | 06-29-2022 | 08-17-2022 | Class II | 131 boxes | Debrox, Carbamide Peroxide, Earwax Removal Aid, 0.5 FL OZ (15 mL) bottle per box), MedTech Products Inc., NDC 63029-321-01. | CGMP Deviations: products were stored outside the drug label specifications. | Terminated |
| D-1324-2022 | 06-29-2022 | 08-17-2022 | Class II | 1 box | 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. | CGMP Deviations: products were stored outside the drug label specifications. | Terminated |
| D-1319-2022 | 06-29-2022 | 08-17-2022 | Class II | 67 bottles | 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. | CGMP Deviations: products were stored outside the drug label specifications. | Terminated |
| D-1326-2022 | 06-29-2022 | 08-17-2022 | Class II | 10 boxes | Sterile Alcohol Prep Pads, Sterile, Latex Free, 100 large pads per box, manufactured for: Dynarex Corporation, NY 10962, NDC 67777-121-16. | CGMP Deviations: products were stored outside the drug label specifications. | Terminated |
Recalled Products
| NDC | Proprietary Name | Non-Proprietary Name | Dosage Form | Route Name | Company Name | Product Type |
|---|---|---|---|---|---|---|
| 0065-0085 | Naphcon A | Naphazoline Hydrochloride And Pheniramine Maleate | Solution/ Drops | Ophthalmic | Alcon Laboratories, Inc. | Human Otc Drug |
| 0065-0429 | Systane Lubricant | Polyethylene Glycol 400 And Propylene Glycol | Solution/ Drops | Ophthalmic | Alcon Laboratories, Inc. | Human Otc Drug |
| 0065-0518 | Genteal Tears NIGHT-TIME | Mineral Oil, White Petrolatum | Ointment | Ophthalmic | Alcon Laboratories, Inc. | Human Otc Drug |
| 0065-0530 | Eye Stream | Purified Water | Solution | Ophthalmic | Alcon Laboratories, Inc. | Human Otc Drug |
| 0065-1433 | Opti-free | Alcon Laboratories, Inc. | ||||
| 0065-1433 | Systane Balance | Propylene Glycol | Emulsion | Ophthalmic | Alcon Laboratories, Inc. | Human Otc Drug |
| 0065-4011 | Zaditor | Ketotifen Fumarate | Solution | Ophthalmic | Alcon Laboratories, Inc. | Human Otc Drug |
| 0065-8150 | Pataday Once Daily Relief | Olopatadine Hydrochloride | Solution | Ophthalmic | Alcon Laboratories, Inc. | Human Otc Drug |
| 0487-2784 | Asthmanefrin | Racepinephrine Hydrochloride | Solution | Respiratory (inhalation) | Nephron Pharmaceuticals Corporation | Human Otc Drug |
| 0487-5901 | S2 | Racepinephrine Hydrochloride | Solution | Respiratory (inhalation) | Nephron Sc, Inc. | Human Otc Drug |
| 11523-0096 | A And D Original | Bayer Healthcare Llc. | ||||
| 11523-0096 | A And D Original | Lanolin And Petrolatum | Ointment | Topical | Bayer Healthcare Llc. | Human Otc Drug |
| 11523-4357 | Miralax | Polyethylene Glycol 3350 | Powder, For Solution | Oral | Bayer Healthcare Llc. | Human Otc Drug |
| 11523-7234 | Miralax | Polyethylene Glycol 3350 | Powder, For Solution | Oral | Bayer Healthcare Llc. | Human Otc Drug |
| 11523-7268 | Miralax | Polyethylene Glycol 3350 | Powder, For Solution | Oral | Bayer Healthcare Llc. | Human Otc Drug |
| 11523-7341 | Miralax | Polyethylene Glycol 3350 | Powder, For Solution | Oral | Bayer Healthcare Llc. | Human Otc Drug |
| 57896-443 | Bisacodyl | Bisacodyl | Suppository | Rectal | Geri-care Pharmaceutical Corp | Human Otc Drug |
| 63029-321 | Debrox | Carbamide Peroxide | Liquid | Auricular (otic) | Medtech Products Inc. | Human Otc Drug |
| 67777-121 | Alcohol Prep | Isopropyl Alcohol | Swab | Topical | Dynarex Corporation | Human Otc Drug |
| 67777-300 | Alcohol | Alcohol | Swab | Topical | Dynarex Corporation | Human Otc Drug |
Recall Enforcement Report D-1320-2022
- Event ID
- 90553 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1320-2022 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is 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 What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide in the USA. What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- GenTeal Tears, Lubricant Eye Ointment, Night-Time Ointment, Sterile, 3.5 gm (0.12 FL OZ) per box, Alcon, NDC 0065-0518-01.
- Reason For Recall
- CGMP Deviations: products were stored outside the drug label specifications. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 40 boxes Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 08-17-2022
- Recall Initiation Date
- 06-29-2022 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 02-13-2024 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Mckesson Medical-Surgical Inc. Corporate Office
- Code Info
- Part# 30065051801 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- 0065-0518-01; 3006505180
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-1327-2022
- Event ID
- 90553 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1327-2022 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is 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 What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide in the USA. What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- 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)
- Reason For Recall
- CGMP Deviations: products were stored outside the drug label specifications. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 08-17-2022
- Recall Initiation Date
- 06-29-2022 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 02-13-2024 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Mckesson Medical-Surgical Inc. Corporate Office
- Code Info
- Part# 1203 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- 67777-300-10; 67777-300-01; 67777-300-12; 67777-300-02; 67777-120-10
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-1323-2022
- Event ID
- 90553 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1323-2022 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is 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 What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide in the USA. What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- 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.
- Reason For Recall
- CGMP Deviations: products were stored outside the drug label specifications. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 113 bottles Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 08-17-2022
- Recall Initiation Date
- 06-29-2022 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 02-13-2024 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Mckesson Medical-Surgical Inc. Corporate Office
- Code Info
- Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-1315-2022
- Event ID
- 90553 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1315-2022 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is 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 What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide in the USA. What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- Eye-stream, eye wash solution, sterile, 4 FL OZ (118 mL) bottle per box, Alcon, NDC 0065-0530-04.
- Reason For Recall
- CGMP Deviations: products were stored outside the drug label specifications. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 16 boxes Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 08-17-2022
- Recall Initiation Date
- 06-29-2022 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 02-13-2024 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Mckesson Medical-Surgical Inc. Corporate Office
- Code Info
- Part# 0065053004 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- 0065-0530-01; 0065-0530-04; 0065053004
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-1316-2022
- Event ID
- 90553 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1316-2022 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is 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 What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide in the USA. What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- 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.
- Reason For Recall
- CGMP Deviations: products were stored outside the drug label specifications. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 12 boxes Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 08-17-2022
- Recall Initiation Date
- 06-29-2022 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 02-13-2024 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Mckesson Medical-Surgical Inc. Corporate Office
- Code Info
- Part# 0065143302 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- 0065-1433-02; 0065-1433-07; 0065-1433-11; 0065143302
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-1312-2022
- Event ID
- 90553 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1312-2022 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is 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 What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide in the USA. What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- Bisacodyl Suppositories, Fast Acting Stimulant Laxative, 100 suppositories per box, 10 mg each, Health Star, NDC 57896-443-01.
- Reason For Recall
- CGMP Deviations: products were stored outside the drug label specifications. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 45 boxes Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 08-17-2022
- Recall Initiation Date
- 06-29-2022 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 02-13-2024 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Mckesson Medical-Surgical Inc. Corporate Office
- Code Info
- Part# 444-01-HST Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- 57896-443-66; 57896-443-12; 57896-443-55; 57896-443-05; 57896-443-01
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-1317-2022
- Event ID
- 90553 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1317-2022 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is 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 What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide in the USA. What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- 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.
- Reason For Recall
- CGMP Deviations: products were stored outside the drug label specifications. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 9 boxes Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 08-17-2022
- Recall Initiation Date
- 06-29-2022 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 02-13-2024 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Mckesson Medical-Surgical Inc. Corporate Office
- Code Info
- Part# 0065401105 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- 0065-4011-05; 0065-4011-06; 0065-4011-11; 0065401105
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-1314-2022
- Event ID
- 90553 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1314-2022 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is 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 What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide in the USA. What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- 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.
- Reason For Recall
- CGMP Deviations: products were stored outside the drug label specifications. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 47 bottles Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 08-17-2022
- Recall Initiation Date
- 06-29-2022 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 02-13-2024 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Mckesson Medical-Surgical Inc. Corporate Office
- Code Info
- Part# a) 0065042915, b) 0065042930 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- 0065-0429-15; 0065-0429-21; 0065-0429-30; 0065-0429-36; 0065-0429-67; 0065042915; 0065042930
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-1321-2022
- Event ID
- 90553 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1321-2022 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is 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 What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide in the USA. What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- 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.
- Reason For Recall
- CGMP Deviations: products were stored outside the drug label specifications. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 1 box Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 08-17-2022
- Recall Initiation Date
- 06-29-2022 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 02-13-2024 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Mckesson Medical-Surgical Inc. Corporate Office
- Code Info
- Part# 00065815001 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- 0065-8150-01; 0065-8150-03; 0065-8150-04; 0065-8150-07; 0006581500
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-1313-2022
- Event ID
- 90553 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1313-2022 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is 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 What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide in the USA. What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- 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.
- Reason For Recall
- CGMP Deviations: products were stored outside the drug label specifications. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 12 boxes Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 08-17-2022
- Recall Initiation Date
- 06-29-2022 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 02-13-2024 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Mckesson Medical-Surgical Inc. Corporate Office
- Code Info
- Part# 0065008515 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- 0065-0085-15; 0065-0085-38; 0065-0085-42; 0065-0085-52; 0065008515
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-1311-2022
- Event ID
- 90553 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1311-2022 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is 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 What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide in the USA. What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- 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.
- Reason For Recall
- CGMP Deviations: products were stored outside the drug label specifications. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 6 boxes Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 08-17-2022
- Recall Initiation Date
- 06-29-2022 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 02-13-2024 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Mckesson Medical-Surgical Inc. Corporate Office
- Code Info
- Part# 231209G Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-1322-2022
- Event ID
- 90553 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1322-2022 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is 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 What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide in the USA. What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- A&D Original Ointment, Diaper Rash Ointment & Skin Protectant, 16 oz. Jar, Bayer Healthcare Pharmaceutica, NDC 11523-0096-3.
- Reason For Recall
- CGMP Deviations: products were stored outside the drug label specifications. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 1 Jar Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 08-17-2022
- Recall Initiation Date
- 06-29-2022 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 02-13-2024 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Mckesson Medical-Surgical Inc. Corporate Office
- Code Info
- Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- 11523-0096-7; 11523-0096-3
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-1325-2022
- Event ID
- 90553 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1325-2022 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is 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 What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide in the USA. What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- 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.
- Reason For Recall
- CGMP Deviations: products were stored outside the drug label specifications. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 23 cartons Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 08-17-2022
- Recall Initiation Date
- 06-29-2022 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 02-13-2024 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Mckesson Medical-Surgical Inc. Corporate Office
- Code Info
- Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- 0487-5901-99
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-1318-2022
- Event ID
- 90553 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1318-2022 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is 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 What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide in the USA. What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- Debrox, Carbamide Peroxide, Earwax Removal Aid, 0.5 FL OZ (15 mL) bottle per box), MedTech Products Inc., NDC 63029-321-01.
- Reason For Recall
- CGMP Deviations: products were stored outside the drug label specifications. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 131 boxes Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 08-17-2022
- Recall Initiation Date
- 06-29-2022 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 02-13-2024 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Mckesson Medical-Surgical Inc. Corporate Office
- Code Info
- Part# 04203710478 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- 63029-321-01; 63029-321-02; 0420371047
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-1324-2022
- Event ID
- 90553 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1324-2022 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is 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 What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide in the USA. What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- 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.
- Reason For Recall
- CGMP Deviations: products were stored outside the drug label specifications. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 1 box Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 08-17-2022
- Recall Initiation Date
- 06-29-2022 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 02-13-2024 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Mckesson Medical-Surgical Inc. Corporate Office
- Code Info
- Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- 0487-2784-01
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-1319-2022
- Event ID
- 90553 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1319-2022 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is 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 What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide in the USA. What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- 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.
- Reason For Recall
- CGMP Deviations: products were stored outside the drug label specifications. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 67 bottles Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 08-17-2022
- Recall Initiation Date
- 06-29-2022 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 02-13-2024 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Mckesson Medical-Surgical Inc. Corporate Office
- Code Info
- Part# 11523723404 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- 11523-7268-3; 11523-7268-8; 11523-7268-7; 11523-7268-4; 11523-7268-9; 11523-7268-5; 11523-7234-1; 11523-7234-2; 11523-7234-3; 11523-7234-4; 11523-7234-5; 11523-7234-6; 11523-7234-9; 11523-7341-1; 11523-7341-2; 11523-4357-1; 11523-4357-3; 11523-4357-5; 11523-4357-2; 1152372340
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-1326-2022
- Event ID
- 90553 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1326-2022 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is 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 What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide in the USA. What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- Sterile Alcohol Prep Pads, Sterile, Latex Free, 100 large pads per box, manufactured for: Dynarex Corporation, NY 10962, NDC 67777-121-16.
- Reason For Recall
- CGMP Deviations: products were stored outside the drug label specifications. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 10 boxes Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 08-17-2022
- Recall Initiation Date
- 06-29-2022 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 02-13-2024 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Mckesson Medical-Surgical Inc. Corporate Office
- Code Info
- Part# 1116 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- 67777-121-14; 67777-121-19; 67777-121-20; 67777-121-16; 67777-121-17; 67777-121-18; 67777-121-13; 67777-121-11; 67777-121-12; 67777-121-27; 67777-121-26; 67777-121-21; 67777-121-22; 67777-121-23; 67777-121-24
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
