August 2018 FDA Recall Drug by Remedyrepack Inc.
D-0093-2019 - CGMP Deviations
This Class II drug recall was voluntarily initiated by Remedyrepack Inc. on August 24, 2018 for the product Drug. The FDA reported the reason for recall as cgmp deviations. The product was distributed in Product was distributed to a medical facility in South Carolina and the recall is currently terminated.
Recall Number: D-0093-2019
CGMP Deviations: Detection of trace amounts of NDMA, a possible impurity or contaminant in an active pharmaceutical ingredient.
08-24-2018
10-31-2018
2 bottles of 90 tablets (180 tablets)
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
RemedyRepack 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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Product was distributed to a medical facility in South Carolina
10-29-2018
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Amlodipine/Valsartan HCTZ 10 mg/320 mg/25 mg tablets, HDPE 90 cc bottles in cardboard trays Original NDC 13668-0325-30 Repackaged NDC 70518-1220-00
Batch or Lot Expiration Information
Lot# B0438903-052118 70518-1220-00
