The Recall Desk
ModerateFDA (Drugs)·D-0377-2019·Announced 2019-01-23

Syntho Pharmaceuticals Recalls EEMT HS Tablets Due to Sub-Potency

Syntho Pharmaceuticals is recalling 5,000 bottles of EEMT HS tablets due to sub-potency and cGMP violations. The product was distributed nationwide.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Syntho Pharmaceuticals, Inc. is recalling 5,000 bottles of EEMT HS (esterified estrogens and methyltestosterone) 0.625 mg/1.25 mg tablets. The recall is due to sub-potency and current Good Manufacturing Practice (cGMP) violations. The affected product is identified by Lot # S16E01 with an expiration date of 05/18.

The product was sold to the firm's sole distributor, who further distributed it throughout the United States. EEMT HS is a prescription-only medication manufactured by Syntho Pharmaceuticals, Inc., in Farmingdale, NY, and distributed by Creekwood Pharmaceutical, Inc., in Birmingham, AL.

Consumers and healthcare providers should stop using the recalled product and return it to the pharmacy or point of purchase. Patients should contact their healthcare provider for alternative treatment options if necessary.

The recalled product

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
Manufacturer
Syntho Pharmaceuticals, Inc.
Category
Drug — Prescription Medication
Hazard
Affected units
5,000

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot #: S16E01
  • Exp 05/18

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 2 recalled by Syntho Pharmaceuticals, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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