CLASS III Drug recall · Reported 19 Dec 2012 · FDA Enforcement Report

Enjuvia (synthetic conjugated estrogens, B) tablets recalled

Physicians Total Care is recalling Enjuvia (synthetic conjugated estrogens, B) tablets, 0.3mg tablets per, distributed in Virginia. The recall was initiated on 8 Apr 2011 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codes62QJ, Exp 12/11

Quantity recalled5 bottles

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-090-2013
FDA event ID: 62924
Recalling firm: Physicians Total Care, Tulsa, OK
Classification: Class III
Status: Terminated
Recall initiated: 8 Apr 2011
FDA classified: 11 Dec 2012
Reported: 19 Dec 2012
Type: Voluntary: Firm initiated
Customers notified by: FAX
Reason category: Potency & Assay

Timeline

8 Apr 2011	Recall initiated by company
11 Dec 2012	Classified by FDA	+613 days
19 Dec 2012	Published in enforcement report	+8 days

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

Reason for recall

Subpotent (Single ingredient) drug : This is a sub recall of Teva's Enjuvia due to low Out of Specification (OOS) assay results.

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

Enjuvia (synthetic conjugated estrogens, B) tablets, 0.3mg, 30-count tablets per bottle, Rx only, Mfg. By: Duramed Pharmaceuticals, Pomona NY 10970; Repacked & distributed by: Physicians Total Care, Inc., Tulsa, OK 74146; NDC 54868-6164-1.

Where it was distributed

Virginia

Questions about this recall

Why was it recalled?

Subpotent (Single ingredient) drug : This is a sub recall of Teva's Enjuvia due to low Out of Specification (OOS) assay results.

Which lots are affected?

62QJ, Exp 12/11

Where was it sold?

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.

Other products in this recall event

2 other products · FDA event 62924

This product is part of a recall event; the main page for the event is Enjuvia (synthetic conjugated estrogens, B) tablets recalled.

Reported	Class	Recall	Company	Reason	Where
19 Dec 2012	CLASS III	Enjuvia (synthetic conjugated estrogens, B) tablets recalled	Physicians Total Care	Potency & Assay	VA
19 Dec 2012	CLASS III	Enjuvia (synthetic conjugated estrogens, B) tablets recalled	Physicians Total Care	Potency & Assay	VA

More recalls from Physicians Total Care

All 21

Reported	Class	Recall	Company	Reason	Where
12 Nov 2014Drug	CLASS II	Cephalexin Monohydrate Capsules,USP, 500 mg recalled	Physicians Total Care	Manufacturing (CGMP) Deviations	GA, MO
12 Nov 2014Drug	CLASS III	Loratadine 24 HR recalled by Physicians Total Care	Physicians Total Care	Other	Nationwide
1 Jan 2014Drug	CLASS II	Carisoprodol IV ( Carisoprodol Tablets USP) 350mg recalled	Physicians Total Care	Lead & Heavy Metals	4 states
7 Aug 2013Drug	CLASS II	Belladonna Alkaloids/PB (Belladonna Alkaloids recalled	Physicians Total Care	Packaging Defects	GA
12 Jun 2013Drug	CLASS III	Voltaren 1% Gel, 100 gm tube recalled by Physicians Total Care	Physicians Total Care	Other	Nationwide

Other Enjuvia (synthetic Conjugated Estrogens recalls

All 3

Reported	Class	Recall	Company	Reason	Where
19 Dec 2012Drug	CLASS III	Enjuvia (synthetic conjugated estrogens, B) tablets recalled	Physicians Total Care	Potency & Assay	VA
19 Dec 2012Drug	CLASS III	Enjuvia (synthetic conjugated estrogens, B) tablets recalled	Physicians Total Care	Potency & Assay	VA