Recall Enforment Report D-0313-2024

Recall Details

Multi event Drug Recall Enforcement Report Class III voluntary initiated by Dr. Reddy's Laboratories, Inc., originally initiated on 01-18-2024 for the product Glimepiride Tablets, USP 1mg, 500-count bottles, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam-532 409 INDIA, NDC: 55111-320-05 The product was recalled due to misprint on tablet. 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-0313-2024	01-18-2024	02-14-2024	Class III	14,425 bottles	Glimepiride Tablets, USP 1mg, 500-count bottles, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam-532 409 INDIA, NDC: 55111-320-05	Misprint on tablet	Ongoing
D-0312-2024	01-18-2024	02-14-2024	Class III	59,336 bottles	Glimepiride Tablets, USP 1mg, 100-count bottles, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam-532 409 INDIA, NDC: 55111-320-01	Misprint on tablet	Ongoing

Recalled Products

NDC	Proprietary Name	Non-Proprietary Name	Dosage Form	Route Name	Company Name	Product Type
55111-320	Glimepiride	Glimepiride	Tablet	Oral	Dr. Reddy's Laboratories Limited	Human Prescription Drug
55111-321	Glimepiride	Glimepiride	Tablet	Oral	Dr. Reddy's Laboratories Limited	Human Prescription Drug
55111-322	Glimepiride	Glimepiride	Tablet	Oral	Dr. Reddy's Laboratories Limited	Human Prescription Drug

Field Name	Field Value
Event ID	93833 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0313-2024 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences. 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 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	Glimepiride Tablets, USP 1mg, 500-count bottles, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam-532 409 INDIA, NDC: 55111-320-05
Reason For Recall	Misprint on tablet What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	14,425 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	02-14-2024
Recall Initiation Date	01-18-2024 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	Dr. Reddy's Laboratories, Inc.
Code Info	Lot: T2303609; Exp. 06/2026 Lot: T2303610; Exp. 06/2026 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	55111-320-30; 55111-320-01; 55111-320-05; 55111-320-79; 55111-320-78; 55111-321-30; 55111-321-01; 55111-321-05; 55111-321-79; 55111-321-78; 55111-322-30; 55111-322-01; 55111-322-05; 55111-322-79; 55111-322-78
Status	Ongoing

Field Name	Field Value
Event ID	93833 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0312-2024 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences. 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 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	Glimepiride Tablets, USP 1mg, 100-count bottles, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam-532 409 INDIA, NDC: 55111-320-01
Reason For Recall	Misprint on tablet What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	59,336 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	02-14-2024
Recall Initiation Date	01-18-2024 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	Dr. Reddy's Laboratories, Inc.
Code Info	Lot: T2303622; Exp. 06/2026 Lot: T2303626; Exp. 06/2026 Lot: T2303627; Exp. 06/2026 Lot: T2303628; Exp. 06/2026 Lot: T2303629; Exp. 06/2026 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	55111-320-30; 55111-320-01; 55111-320-05; 55111-320-79; 55111-320-78; 55111-321-30; 55111-321-01; 55111-321-05; 55111-321-79; 55111-321-78; 55111-322-30; 55111-322-01; 55111-322-05; 55111-322-79; 55111-322-78
Status	Ongoing