CLASS III Drug recall · Reported 25 Jan 2017 · FDA Enforcement Report

HCG (Chorionic Gonadotropin Lyopholized) II vial recalled

Town and Country Compounding and Consultation Services is recalling HCG (Chorionic Gonadotropin Lyopholized) II vial, distributed nationwide in the US. The recall was initiated on 18 Oct 2016 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesLot #: 05272016@17
Quantity recalled101 vials

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number
D-0436-2017
FDA event ID
75700
Classification
Class III
Status
Terminated
Recall initiated
18 Oct 2016
FDA classified
19 Jan 2017
Reported
25 Jan 2017
Type
Voluntary: Firm initiated
Customers notified by
Letter
Reason category
Potency & Assay

Timeline

18 Oct 2016Recall initiated by company
19 Jan 2017Classified by FDA+93 days
25 Jan 2017Published in enforcement report+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Subpotent Drug: due to failed potency results of 74% (spec. 80-125%).

Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.

Product as listed by the FDA

HCG (Chorionic Gonadotropin Lyopholized) II, 1000 unit vial, Rx only, Prepared by Town & Country, Compounding & Consultation Services, 106 Prospect St - 1st FL, Ridgewood, NJ 07459

Where it was distributed

Nationwide

Nationwide

Questions about this recall

Why was it recalled?

Subpotent Drug: due to failed potency results of 74% (spec. 80-125%).

Which lots are affected?

Lot #: 05272016@17

Where was it sold?

Nationwide

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class III mean?

Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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