Recall Enforment Report D-0108-2024

Recall Details

Multi event Drug Recall Enforcement Report Class I voluntary initiated by The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories, originally initiated on 10-31-2023 for the product Lubricating Tears Eye Drops (Dextran/Hypromellose), 0.1%/0.3%, packaged in 0.5 FL OZ (15mL) bottles, Distributed by: RUGBY LABORATORIES, Livonia, MI 48152, NDC 0536-1282-94 The product was recalled due to non-sterility: fda found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.. The product was distributed nationwide and the recall is currently ongoing.

Recall Enforcement Reports

Recall Number	Recall Initiation Date	Report Date	Recall Classification	Quantity	Product Description	Recall Reason	Status
D-0108-2024	10-31-2023	11-29-2023	Class I	65,880 bottles	Lubricating Tears Eye Drops (Dextran/Hypromellose), 0.1%/0.3%, packaged in 0.5 FL OZ (15mL) bottles, Distributed by: RUGBY LABORATORIES, Livonia, MI 48152, NDC 0536-1282-94	Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.	Ongoing
D-0107-2024	10-31-2023	11-29-2023	Class I	1,271,810 bottles	Polyvinyl Alcohol 1.4% Lubricating Eye Drops, packaged in 0.5 FL OZ (15mL) bottles, Dist. by: RUGBY LABORATORIES, Livonia, MI 48152, NDC 0536-1325-94.	Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.	Ongoing

Field Name	Field Value
Event ID	93339 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0108-2024 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death. 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 within the United States 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	Lubricating Tears Eye Drops (Dextran/Hypromellose), 0.1%/0.3%, packaged in 0.5 FL OZ (15mL) bottles, Distributed by: RUGBY LABORATORIES, Livonia, MI 48152, NDC 0536-1282-94
Reason For Recall	Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility. What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	65,880 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	11-29-2023
Recall Initiation Date	10-31-2023 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of 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	The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Code Info	All lots 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.
Status	Ongoing

Field Name	Field Value
Event ID	93339 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0107-2024 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death. 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 within the United States 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	Polyvinyl Alcohol 1.4% Lubricating Eye Drops, packaged in 0.5 FL OZ (15mL) bottles, Dist. by: RUGBY LABORATORIES, Livonia, MI 48152, NDC 0536-1325-94.
Reason For Recall	Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility. What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	1,271,810 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	11-29-2023
Recall Initiation Date	10-31-2023 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of 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	The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Code Info	All lots 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.
Status	Ongoing