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
Reported: January 23, 2019 Initiated: April 17, 2017 #D-0378-2019
Product Description
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
Reason for Recall
CGMP deviations: Lots were recalled due to sub-potency and cGMP violations.
Details
- Recalling Firm
- Syntho Pharmaceuticals, Inc.
- Units Affected
- 5,000 bottles
- Distribution
- Product was sold to the firm's sole distributor who further distributed the product throughout the United States.
- Location
- Farmingdale, NY
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Syntho Pharmaceuticals, Inc.. Units affected: 5,000 bottles.
Why was this product recalled? ▼
CGMP deviations: Lots were recalled due to sub-potency and cGMP violations.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on January 23, 2019. Severity: Moderate. Recall number: D-0378-2019.
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