Physicians Total Care Recalls Subpotent Enjuvia Tablets
Physicians Total Care is recalling specific lots of Enjuvia tablets because they failed potency tests. The affected medication may contain less active ingredient than labeled.
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 the rubric defines as unlikely to cause adverse health consequences. The hazard is a subpotent drug, which is a quality issue rather than a direct safety threat like contamination or mislabeling of a dangerous substance.
Plain-English summary
Physicians Total Care, Inc. is recalling specific lots of Enjuvia (synthetic conjugated estrogens, B) tablets, 0.625 mg. The recall involves 9 bottles of the 30-count prescription medication. The product was manufactured by Teva Pharmaceuticals USA and repacked and distributed by Physicians Total Care, Inc.
The recall was initiated because the medication produced low Out of Specification (OOS) assay results, indicating that the tablets are subpotent. This means the medication may not contain the full amount of the active ingredient stated on the label. The affected lots are identified by Lot # 62QI (Expiration 01/12) and Lot # 6DYQ (Expiration 08/12).
The distribution pattern is listed as VA. Patients who have been prescribed this specific medication should consult their healthcare provider for guidance on alternative treatments or further instructions.
The recalled product
- Product
- Enjuvia (synthetic conjugated estrogens, B) tablets, 0.625 mg, 30-count tablets per bottle, Rx only, Mfg. By: Teva Pharmaceuticals USA, Sellersville PA 18960; Repacked & distributed by: Physicians Total Care, Inc., Tulsa, OK 74146; NDC 54868-6163-1.
- Manufacturer
- Physicians Total Care, Inc.
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 9
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 (4)
- Lot #: 62QI
- Exp 01/12
- 6DYQ
- Exp 08/12
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.
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