Multi-event March 2022 FDA Recall Enalapril Maleate by Golden State Medical Supply Inc.
This Multi-event Class II drug recall was voluntarily initiated by Golden State Medical Supply Inc. on March 16, 2022 for the product Enalapril Maleate. The FDA reported the reason for recall as cgmp deviations. The product was distributed Nationwide and the recall is currently ongoing.
Reported Recall Events
Recall Number: D-1179-2022
CGMP Deviations
03-16-2022
07-13-2022
31,260 bottles
Recall Profile & Regulatory Data
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Golden State Medical Supply Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the U.S: PA, MA, OH, TX, IL, ND, HI
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Enalapril Maleate Tablets, USP; 10 mg; 90 tablets, NDC 60429-185-90; manufactured by Taro Pharmaceutical Industries, Ltd.; packaged by GSMS, Incorporated, CA.
Batch or Lot Expiration Information
Lot# 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).
Affected Packages Involved in this Recall
Recall Number: D-1178-2022
CGMP Deviations
03-16-2022
07-13-2022
9,058
Recall Profile & Regulatory Data
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Golden State Medical Supply Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the U.S: PA, MA, OH, TX, IL, ND, HI
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Enalapril Maleate Tablets, USP; 5 mg; 90 tablets, NDC 60429-184-90; manufactured by Taro Pharmaceutical Industries, Ltd.; packaged by GSMS, Incorporated, CA.
Batch or Lot Expiration Information
Lot# 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.
Affected Packages Involved in this Recall
Recall Number: D-1180-2022
CGMP Deviations
03-16-2022
07-13-2022
1,424 bottles
Recall Profile & Regulatory Data
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Golden State Medical Supply Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the U.S: PA, MA, OH, TX, IL, ND, HI
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Enalapril Maleate Tablets, USP; 20 mg; 90 tablets, NDC 60429-186-90; manufactured by Taro Pharmaceutical Industries, Ltd.; packaged by GSMS, Incorporated, CA.
Batch or Lot Expiration Information
Lot# 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).
Affected Packages Involved in this Recall
Recall Number: D-1177-2022
CGMP Deviations
03-16-2022
07-13-2022
1,471 bottles
Recall Profile & Regulatory Data
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Golden State Medical Supply Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the U.S: PA, MA, OH, TX, IL, ND, HI
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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.
Batch or Lot Expiration Information
Lot# 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).
