Physicians Total Care Recalls Subpotent Enjuvia Tablets
Physicians Total Care is recalling 5 bottles of Enjuvia tablets due to low assay results. The medication was distributed in Virginia.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 III, which indicates the product is not likely to cause adverse health consequences. The hazard is a subpotent drug, which is a quality issue rather than a direct safety hazard like contamination or injury.
Plain-English summary
Physicians Total Care, Inc. is recalling 5 bottles of Enjuvia (synthetic conjugated estrogens, B) tablets, 0.3mg. The recall involves a specific lot with code 62QJ and an expiration date of 12/11. The product was manufactured by Duramed Pharmaceuticals and repacked and distributed by Physicians Total Care, Inc.
The recall was initiated because the medication failed to meet quality standards, specifically showing low Out of Specification (OOS) assay results. This indicates that the tablets contain less of the active ingredient than required, making them subpotent. The recall is described as a sub recall of Teva's Enjuvia.
The affected product was distributed in Virginia (VA). Patients who have this specific medication should contact their healthcare provider or pharmacist for guidance on how to proceed.
The recalled product
- Product
- 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.
- Manufacturer
- Physicians Total Care, Inc.
- Category
- Drug — Prescription Medication
- Hazard
- 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)
- 62QJ
- Exp 12/11
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.
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