Agency classClass IIOur severity:Moderate FDA (Drugs)·D-0378-2019·Announced 2019-01-23

Syntho Recalls EEMT Tablets Due to Sub-Potency and cGMP Violations

Syntho Pharmaceuticals is recalling 5,000 bottles of EEMT tablets because they were found to be sub-potent and involved cGMP violations.

The agency’s classification

FDA (Drugs): Class II

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.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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, which typically indicates a situation where use of the product might cause temporary or medically reversible health consequences. The hazard is sub-potency (lower than labeled potency) rather than contamination or acute toxicity, fitting the Moderate severity criteria for low-risk quality issues without reported serious injury.

Plain-English summary

Syntho Pharmaceuticals, Inc. is recalling 5,000 bottles of EEMT (esterified estrogens and methyltestosterone) 1.25 mg/2.5 mg tablets. The product is a prescription-only medication manufactured by Syntho Pharmaceuticals, Inc., in Farmingdale, NY, and distributed by Creekwood Pharmaceutical, Inc., in Birmingham, AL. The specific lot affected is S16E02, with an expiration date of 05/18.

The recall was initiated due to Current Good Manufacturing Practice (cGMP) deviations. Specifically, the lots were recalled because they were found to be sub-potent, meaning they did not contain the full amount of active ingredients required by the label. The product was sold to the firm's sole distributor, who then distributed it throughout the United States.

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

The recalled product

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
Manufacturer: Syntho Pharmaceuticals, Inc.
Category: Drug — Prescription Medication
Hazard: sub-potency
cGMP-violation
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 #: S16E02
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 →

Same manufacturer · Syntho Pharmaceuticals, Inc.

See all →

Moderate
Syntho Pharmaceuticals Recalls EEMT HS Tablets Due to Sub-Potency
FDA (Drugs) · 2019-01-23

Same hazard · sub potency