Multi-event July 2018 FDA Recall Drug by A-s Medication Solutions Llc.

This Multi-event Class II drug recall was voluntarily initiated by A-s Medication Solutions Llc. on July 17, 2018 for the product Drug. The FDA reported the reason for recall as cgmp deviations. The product was distributed Nationwide and the recall is currently ongoing.

Reported Recall Events

D-1109-2018 ONGOING D-1108-2018 ONGOING D-1111-2018 ONGOING D-1110-2018 ONGOING

Recall Number: D-1109-2018

Reason for Recall
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Initiated
07-17-2018
Reported
08-29-2018
Quantity
178 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80748
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
A-S Medication Solutions LLC.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide USA
Product Description About Product Description
Full technical description of the product.
Valsartan Tablets, 80 MG, 30-count bottle (NDC 54569-6582-0, 90-count bottle (NDC 54569-6582-1), Rx Only, MFG: Zhejiang Huahai Pharma, Linhai, Zhejiang 317024 China

Batch or Lot Expiration Information

Lot# Expiry, lot: [30-count] 11/30/2018: 7258177, 7276228; 2/28/2019: 7212260; [90-count] 11/30/2018: 7208140; 2/28/2019: 7212261, 7221155, 7222161; 8/31/2019: 8109171; 9/30/2019: 8109170

Recall Number: D-1108-2018

Reason for Recall
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Initiated
07-17-2018
Reported
08-29-2018
Quantity
666 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80748
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
A-S Medication Solutions LLC.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide USA
Product Description About Product Description
Full technical description of the product.
Valsartan Tablets, 160 MG, 30-count bottle (NDC 54569-6583-0), 90-count bottle (NDC 54569-6583-1), Rx Only, MFG: Zhejiang Huahai Pharma, Linhai, Zhejiang 317024 China

Batch or Lot Expiration Information

Lot# Expiry, lot: [30-count] 2/28/2019: 7285177; 3/31/2019: 7222163, 7227175; 8/31/2019: 8162190, 8183227. [90-count] 2/28/2019: 7207135, 7212280, 7215073; 3/31/2019: 7222162; 8/31/2019: 8095248, 8095249

Recall Number: D-1111-2018

Reason for Recall
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Initiated
07-17-2018
Reported
08-29-2018
Quantity
531 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80748
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
A-S Medication Solutions LLC.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide USA
Product Description About Product Description
Full technical description of the product.
Valsartan and Hydrochlorothiazide Tablets, Valsartan 320 MG and Hydrochlorothiazide 25 MG, 90 tablets per bottle, Rx Only, MFG: Arrow Pharm (Malta) LTD, Birzebbugia, BBG 3000 Malta. NDC: 54569-6488-0

Batch or Lot Expiration Information

Lot# Expiry, lot: 1/31/2019: 7293219; 6/30/2019: 7362231, 8074161, 8110184, 8197215, 8114178, 8115123; 9/30/2018: 7132187, 7160161, 7180150, 7268239

Recall Number: D-1110-2018

Reason for Recall
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Initiated
07-17-2018
Reported
08-29-2018
Quantity
524 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80748
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
A-S Medication Solutions LLC.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide USA
Product Description About Product Description
Full technical description of the product.
Valsartan and Hydrochlorothiazide Tablets, Valsartan 160 MG and Hydrochlorothiazide 12.5 MG, 90 tablets per bottle, Rx Only, MFG: Arrow Pharm (Malta) LTD, Birzebbugia, BBG 3000 Malta. NDC: 54569-6480-0

Batch or Lot Expiration Information

Lot# Expiry, lot: 4/30/2019: 8033130; 7/31/2019: 8068192, 8110183, 8080157, 8190195