Multi-event July 2021 FDA Recall Drug by Api Solutions Inc.

This Multi-event Class II drug recall was voluntarily initiated by Api Solutions Inc. on July 15, 2021 for the product Drug. The FDA reported the reason for recall as cgmp deviations. The product was distributed in AL, AZ, CO, FL, VA and the recall is currently terminated.

Reported Recall Events

D-0695-2021 TERMINATED D-0696-2021 TERMINATED

Recall Number: D-0695-2021

Reason for Recall
cGMP Deviations
Initiated
07-15-2021
Reported
08-04-2021
Quantity
20 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
88289
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
API Solutions Inc.
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.
AL, AZ, CO, FL, VA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-08-2022
Product Description About Product Description
Full technical description of the product.
Estriol USP41 Micro 25 Grams, Distributed by: A.P.I. Solutions 25309 Friendship Rd Daphne, AL Distributed by: Syntec Pharma Corp., NY MFT by: Wuhan Fortune Chemical Co., Ltd., China, NDC: 46144-300-01

Batch or Lot Expiration Information

Lot# : ETL181001, Exp 10/09/2021

Recall Number: D-0696-2021

Reason for Recall
cGMP Deviations
Initiated
07-15-2021
Reported
08-04-2021
Quantity
1 bottle

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
88289
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
API Solutions Inc.
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.
AL, AZ, CO, FL, VA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-08-2022
Product Description About Product Description
Full technical description of the product.
Azelaic Acid 99.0+% Micro 500 Grams, Distributed By: A.P.I. Solutions Daphne Alabama Manufactured by: Yicheng Chemicals Corp. China Distributed by: Syntec Pharma Corp New York

Batch or Lot Expiration Information

Lot# : AZA181105, Exp 11/09/2021