EEMT (esterified estrogens and methyltestosterone) 1.25 recall: CGMP Deviations
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
Why was EEMT (esterified estrogens and methyltestosterone) 1.25 recalled?
CGMP deviations: Lots were recalled due to sub-potency and cGMP violations.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: S16E02, Exp 05/18
- 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
- Recalling firm
- Syntho Pharmaceuticals, Inc.
- Quantity
- 5,000 bottles
- Distribution
- Product was sold to the firm's sole distributor who further distributed the product throughout the United States.
- Recall date
- January 23, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)