Recall Enforment Report D-1292-2022

Drug Recall Enforcement Report Class I voluntary initiated by Mylan Pharmaceuticals Inc, originally initiated on 07-05-2022 for the product Insulin Glargine (Insulin glargine-yfgn) Injection, 100 units/mL (U-100), 3 mL prefilled pens (NDC 49502-394-71), packaged in cartons of 5 prefilled pens (NDC 49502-394-75), Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 15317, Manufactured for: Mylan Specialty L.P., Morgantown, WV The product was recalled due to labeling: missing label: label missing from some prefilled pens.. The product was distributed nationwide and the recall is currently terminated.

Field Name	Field Value
Event ID	90545 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-1292-2022 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class 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	Product was distributed 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	Insulin Glargine (Insulin glargine-yfgn) Injection, 100 units/mL (U-100), 3 mL prefilled pens (NDC 49502-394-71), packaged in cartons of 5 prefilled pens (NDC 49502-394-75), Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 15317, Manufactured for: Mylan Specialty L.P., Morgantown, WV
Reason For Recall	Labeling: Missing label: Label missing from some prefilled pens. What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	253,200 pens (50,650/5 per packs) 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	08-03-2022
Recall Initiation Date	07-05-2022 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	02-26-2024 What is the Date Terminated? The date that FDA terminated the recall.
Initial Firm Notification	Press Release 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	Mylan Pharmaceuticals Inc
Code Info	Lot #: BF21002895, Exp. Date Aug 2023 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	49502-394-71; 49502-394-75; 49502-393-80
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.

Recalled Products