Multi-event April 2017 FDA Recall Drug by Syntho Pharmaceuticals, Inc.
This Multi-event Class II drug recall was voluntarily initiated by Syntho Pharmaceuticals, Inc. on April 17, 2017 for the product Drug. The FDA reported the reason for recall as cgmp deviations. The product was distributed in Product was sold to the firm's sole distributor who further distributed the product throughout the United States. and the recall is currently terminated.
Reported Recall Events
Recall Number: D-0377-2019
CGMP deviations: Lots were recalled due to sub-potency and cGMP violations.
04-17-2017
01-23-2019
5,000 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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Syntho Pharmaceuticals, 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 sold to the firm's sole distributor who further distributed the product throughout the United States.
03-27-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
EEMT HS (esterified estrogens and methyltestosterone) 0.625 mg/1.25 mg, tablets,100-count bottle, Rx only, Manufactured By: Syntho Pharmaceuticals, Inc., Farmingdale, NY 11735, Distributed By: Creekwood Pharmaceutical, Inc., Birmingham, AL 35242, NDC 15310-020-01
Batch or Lot Expiration Information
Lot# : S16E01, Exp 05/18
Recall Number: D-0378-2019
CGMP deviations: Lots were recalled due to sub-potency and cGMP violations.
04-17-2017
01-23-2019
5,000 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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Syntho Pharmaceuticals, 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 sold to the firm's sole distributor who further distributed the product throughout the United States.
03-27-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
EEMT (esterified estrogens and methyltestosterone) 1.25 mg/2.5 mg, tablets,100-count bottle, Rx only, Manufactured By: Syntho Pharmaceuticals, Inc., Farmingdale, NY 11735, Distributed By: Creekwood Pharmaceutical, Inc., Birmingham, AL 35242, NDC 15310-010-01
Batch or Lot Expiration Information
Lot# : S16E02, Exp 05/18
