The Recall Desk
LowFDA (Drugs)·D-092-2013·Announced 2012-12-19

Physicians Total Care Recalls Subpotent Enjuvia Tablets

Physicians Total Care is recalling Enjuvia tablets due to low assay results. The recall is limited to a specific lot and expiration date.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The agency classified this as an FDA Class III recall, which is defined as unlikely to cause adverse health consequences. The hazard is a subpotent drug, which is a documentation and quality control issue rather than an immediate safety threat like contamination or mislabeling of a dangerous substance.

Plain-English summary

Physicians Total Care, Inc. is recalling Enjuvia (synthetic conjugated estrogens, B) tablets, 0.9mg. The recall involves 5 bottles of 30-count tablets, NDC 54868-6165-1. The product was manufactured by Duramed Pharmaceuticals and repacked and distributed by Physicians Total Care, Inc.

The recall was initiated because the product is subpotent, meaning it contains less of the active ingredient than required. This was identified through low Out of Specification (OOS) assay results. The specific lot number is 62QH, with an expiration date of 4/12.

The distribution pattern is listed as VA. Consumers and healthcare providers should check their inventory for this specific lot and expiration date. If found, the product should be returned to the distributor or disposed of according to local regulations. Patients should consult their healthcare provider for alternative treatment options if necessary.

The recalled product

Product
Enjuvia (synthetic conjugated estrogens, B) tablets, 0.9mg, 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 54868-6165-1.
Affected units
5

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 # 62QH
  • Exp 4/12

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 3 recalled by Physicians Total Care, 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 3 products in this recall →