- Home
- Labeler Index
- Golden State Medical Supply, Inc.
- 60429-184
- FDA Recall: Enalapril Maleate
FDA Recall Enalapril Maleate
View Recall Number, Date, Reasons, Quantity
FDA Recall Enforcement Reports
The last Recall Enforcement Report for Enalapril Maleate with NDC 60429-184 was initiated on 03-16-2022 as a Class II recall due to cgmp deviations The latest recall number for this product is D-1179-2022 and the recall is currently ongoing .
| Recall Number | Initiation Date | Report Date | Recall Classification | Product Quantity | Product Description | Status |
|---|---|---|---|---|---|---|
| D-1179-2022 | 03-16-2022 | 07-13-2022 | Class II | 31,260 bottles | Enalapril Maleate Tablets, USP; 10 mg; 90 tablets, NDC 60429-185-90; manufactured by Taro Pharmaceutical Industries, Ltd.; packaged by GSMS, Incorporated, CA. | Ongoing |
| D-1178-2022 | 03-16-2022 | 07-13-2022 | Class II | 9,058 | Enalapril Maleate Tablets, USP; 5 mg; 90 tablets, NDC 60429-184-90; manufactured by Taro Pharmaceutical Industries, Ltd.; packaged by GSMS, Incorporated, CA. | Ongoing |
| D-1177-2022 | 03-16-2022 | 07-13-2022 | Class II | 1,471 bottles | Enalapril Maleate Tablets, USP; 2.5 mg; 90 tablets, NDC 60429-183-90; manufactured by Taro Pharmaceutical Industries, Ltd.; packaged by GSMS, Incorporated, CA, USA. | Ongoing |
| D-1180-2022 | 03-16-2022 | 07-13-2022 | Class II | 1,424 bottles | Enalapril Maleate Tablets, USP; 20 mg; 90 tablets, NDC 60429-186-90; manufactured by Taro Pharmaceutical Industries, Ltd.; packaged by GSMS, Incorporated, CA. | Ongoing |
What is the Enforcement Report?
All drug recalls are monitored by the Food and Drug Administration (FDA) and are included in the Enforcement Report once they are properly classified. The FDA will determine if a firm's removal or correction actions of a marked product meet the requirements to be considered a "recall". The FDA will also determine the public hazard assessment and a recall classification will be published in the Enforcement Report.
Recall Enforcement Report D-1179-2022
- Event ID
- 89863 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1179-2022 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 U.S: PA, MA, OH, TX, IL, ND, HI 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
- Enalapril Maleate Tablets, USP; 10 mg; 90 tablets, NDC 60429-185-90; manufactured by Taro Pharmaceutical Industries, Ltd.; packaged by GSMS, Incorporated, CA.
- Reason For Recall
- CGMP Deviations What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 31,260 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
- 07-13-2022
- Recall Initiation Date
- 03-16-2022 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
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit 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
- Golden State Medical Supply Inc.
- Code Info
- Lots: GS027890, GS028177, GS028488, 10 mg; 90 tablets, Exp.: 04/2022; Lots: GS028847, GS028848, Exp.: 09/2022; GS029627, GS029862,GS030057, GS030481, GS030870, GS031060, GS031437, GS031438, GS033527, GS034231, Exp.: 10/2022; Lots: GS034810, Exp.: 01/2023; Lots: GS035240, GS035598, Exp.: 05/2023; Lots: GS036194, Exp.: 06/2023; Lots: GS036760, GS036981,GS037526, GS038177, GS038728, Exp.: 08/2023; Lots: GS038729, GS041108, Exp.: 09/2023; Lots: GS039412, GS039840, GS041109, Exp.: 12/2023; Lot: GS041655, Exp.: 01/2024; Lot: GS041656, Exp.: 05/2024. (NDC: 60429-185-90). 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
- 60429-183-30; 60429-183-10; 60429-183-90; 60429-184-30; 60429-184-10; 60429-184-90; 60429-185-30; 60429-185-10; 60429-185-90; 60429-186-30; 60429-186-10; 60429-186-90
- Status
- Ongoing
Recall Enforcement Report D-1178-2022
- Event ID
- 89863 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1178-2022 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 U.S: PA, MA, OH, TX, IL, ND, HI 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
- Enalapril Maleate Tablets, USP; 5 mg; 90 tablets, NDC 60429-184-90; manufactured by Taro Pharmaceutical Industries, Ltd.; packaged by GSMS, Incorporated, CA.
- Reason For Recall
- CGMP Deviations What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 9,058 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
- 07-13-2022
- Recall Initiation Date
- 03-16-2022 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
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit 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
- Golden State Medical Supply Inc.
- Code Info
- Lot: GS029041, GS029353, GS02986, 5 mg; 90 tablets, Exp.: 09/2022; Lot: GS030056, GS030869, GS033943, Exp.: 10/2022; Lots: GS034490, GS035197, Exp.:02/2023; Lots: GS035198, Exp.: 03/2023; Lots: GS035596, GS035947, GS036759, GS037400, Exp.: 06/2023; Lots: GS038089, GS038763, GS039559, GS040150, Exp.: 10/2023; Lots: GS040151, GS040708, GS041107, Exp.: 12/2023; Lot: GS041654, Exp.: 03/2024. 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
- 60429-183-30; 60429-183-10; 60429-183-90; 60429-184-30; 60429-184-10; 60429-184-90; 60429-185-30; 60429-185-10; 60429-185-90; 60429-186-30; 60429-186-10; 60429-186-90
- Status
- Ongoing
Recall Enforcement Report D-1177-2022
- Event ID
- 89863 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1177-2022 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 U.S: PA, MA, OH, TX, IL, ND, HI 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
- Enalapril Maleate Tablets, USP; 2.5 mg; 90 tablets, NDC 60429-183-90; manufactured by Taro Pharmaceutical Industries, Ltd.; packaged by GSMS, Incorporated, CA, USA.
- Reason For Recall
- CGMP Deviations What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 1,471 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
- 07-13-2022
- Recall Initiation Date
- 03-16-2022 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
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit 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
- Golden State Medical Supply Inc.
- Code Info
- Lots: GS028301, 2.5 mg; 90 tablets, Exp.: 06/2022; Lots: GS029973, GS029974, GS031436, GS031715, GS033191, GS033940, Exp. : 10/2022; Lot: GS034212, Exp.: 12/2022; Lot: GS035315, GS035945, GS036905, GS038038, GS039199, Exp.: 04/2023; Lot: GS039200, GS040149, Exp.: 11/2023. (NDC: 60429-183-90). 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
- 60429-183-30; 60429-183-10; 60429-183-90; 60429-184-30; 60429-184-10; 60429-184-90; 60429-185-30; 60429-185-10; 60429-185-90; 60429-186-30; 60429-186-10; 60429-186-90
- Status
- Ongoing
Recall Enforcement Report D-1180-2022
- Event ID
- 89863 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1180-2022 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 U.S: PA, MA, OH, TX, IL, ND, HI 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
- Enalapril Maleate Tablets, USP; 20 mg; 90 tablets, NDC 60429-186-90; manufactured by Taro Pharmaceutical Industries, Ltd.; packaged by GSMS, Incorporated, CA.
- Reason For Recall
- CGMP Deviations What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 1,424 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
- 07-13-2022
- Recall Initiation Date
- 03-16-2022 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
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit 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
- Golden State Medical Supply Inc.
- Code Info
- Lots: GS035031, GS035199, 20 mg; 90 tablets, Exp.: 03/2022; Lots: GS036495, GS036904, Exp.: 05/2022; Lots: GS037401, Exp.: 09/2022; Lots: GS037986, GS038359, GS039560, Exp.: 11/2022; Lot: GS041110, Exp.: 12/2022. (NDC: 60429-186-90). 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
- 60429-183-30; 60429-183-10; 60429-183-90; 60429-184-30; 60429-184-10; 60429-184-90; 60429-185-30; 60429-185-10; 60429-185-90; 60429-186-30; 60429-186-10; 60429-186-90
- Status
- Ongoing