Recall Enforment Report D-0113-2024

Recall Details

Multi event Drug Recall Enforcement Report Class III voluntary initiated by NCS Healthcare of Kentucky Inc, originally initiated on 10-27-2023 for the product Buspirone Hydrochloride Tabs USP 10 mg, packaged in a) 15-count blister card (NDC 0615-7718-05) b) 30-count blister card (NDC 0615-7718-39), Rx only, Mfd By Pliva HRVATSKA for Teva USA, PKG by Vangard Glasgow, KY 42141. The product was recalled due to presence of foreign tablets: potential of stray tablet(s) of amlodipine besylate 10 mg tablet within the recalled lots. 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-0113-2024	10-27-2023	11-29-2023	Class III	1,344 cards	Buspirone Hydrochloride Tabs USP 10 mg, packaged in a) 15-count blister card (NDC 0615-7718-05) b) 30-count blister card (NDC 0615-7718-39), Rx only, Mfd By Pliva HRVATSKA for Teva USA, PKG by Vangard Glasgow, KY 42141.	Presence of Foreign Tablets: Potential of stray tablet(s) of Amlodipine Besylate 10 mg Tablet within the recalled lots	Ongoing
D-0114-2024	10-27-2023	11-29-2023	Class III	12 cards	Lisinopril Tablets USP 20 mg, packaged in a) 15-count blister card (NDC 0615-7718-05), b) 30-count blister card (NDC 0615-8255-39), Rx only, Mfd By Lupin, PKG by Vangard Glasgow, KY 42141.	Presence of Foreign Tablets: Potential of stray tablet(s) of Amlodipine Besylate 10 mg Tablet within the recalled lots	Ongoing

Recalled Products

NDC	Proprietary Name	Non-Proprietary Name	Dosage Form	Route Name	Company Name	Product Type
0615-7689	Buspirone Hydrochloride	Buspirone Hydrochloride	Tablet	Oral	Ncs Healthcare Of Ky, Llc Dba Vangard Labs	Human Prescription Drug
0615-7714	Buspirone Hydrochloride	Buspirone Hydrochloride	Tablet	Oral	Ncs Healthcare Of Ky, Llc Dba Vangard Labs	Human Prescription Drug
0615-7718	Buspirone Hydrochloride	Buspirone Hydrochloride	Tablet	Oral	Ncs Healthcare Of Ky, Llc Dba Vangard Labs	Human Prescription Drug
0615-8252	Lisinopril	Lisinopril	Tablet	Oral	Ncs Healthcare Of Ky, Llc Dba Vangard Labs	Human Prescription Drug
0615-8253	Lisinopril	Lisinopril	Tablet	Oral	Ncs Healthcare Of Ky, Llc Dba Vangard Labs	Human Prescription Drug
0615-8254	Lisinopril	Lisinopril	Tablet	Oral	Ncs Healthcare Of Ky, Llc Dba Vangard Labs	Human Prescription Drug
0615-8255	Lisinopril	Lisinopril	Tablet	Oral	Ncs Healthcare Of Ky, Llc Dba Vangard Labs	Human Prescription Drug

Field Name	Field Value
Event ID	93336 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0113-2024 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 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	Buspirone Hydrochloride Tabs USP 10 mg, packaged in a) 15-count blister card (NDC 0615-7718-05) b) 30-count blister card (NDC 0615-7718-39), Rx only, Mfd By Pliva HRVATSKA for Teva USA, PKG by Vangard Glasgow, KY 42141.
Reason For Recall	Presence of Foreign Tablets: Potential of stray tablet(s) of Amlodipine Besylate 10 mg Tablet within the recalled lots What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	1,344 cards 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	10-27-2023 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	NCS Healthcare of Kentucky Inc
Code Info	Lot#: a) 7718-3008, Exp 08/31/2024; b) 7718-3008, Exp 08/31/2024 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	0615-7689-39; 0615-7689-31; 0615-7689-05; 0615-7718-39; 0615-7718-31; 0615-7718-05; 0615-7714-39; 0615-7714-30; 0615-7714-05
Status	Ongoing

Field Name	Field Value
Event ID	93336 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0114-2024 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 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	Lisinopril Tablets USP 20 mg, packaged in a) 15-count blister card (NDC 0615-7718-05), b) 30-count blister card (NDC 0615-8255-39), Rx only, Mfd By Lupin, PKG by Vangard Glasgow, KY 42141.
Reason For Recall	Presence of Foreign Tablets: Potential of stray tablet(s) of Amlodipine Besylate 10 mg Tablet within the recalled lots What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	12 cards 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	10-27-2023 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	NCS Healthcare of Kentucky Inc
Code Info	Lot#: a) 8255-3012, Exp 08/31/2024; b) 8255-3012, Exp 08/31/2024 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	0615-7689-39; 0615-7689-31; 0615-7689-05; 0615-7718-39; 0615-7718-31; 0615-7718-05; 0615-7714-39; 0615-7714-30; 0615-7714-05; 0615-8252-39; 0615-8252-05; 0615-8253-39; 0615-8253-05; 0615-8253-30; 0615-8254-05; 0615-8254-39; 0615-8254-30; 0615-8255-39; 0615-8255-05; 0615-8255-30; 0615-8256-39; 0615-8256-05
Status	Ongoing