Pfizer Recalls Prempro Tablets Due to Dissolution Specification Failures
Pfizer is recalling specific lots of Prempro tablets because they may not meet dissolution specifications for conjugated estrogens.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The source text identifies this as an FDA Class III recall, which the rubric defines as typically scoring 1 or 2 because it is unlikely to cause adverse health consequences.
Plain-English summary
Pfizer Inc. is recalling Prempro (conjugated estrogens/medroxyprogesterone acetate tablets) 0.625 mg/2.5 mg. The recall involves 432,657 blister cards, each containing 28 tablets, distributed nationwide and in Puerto Rico. The affected lots are E67324 and E96152, with an expiration date of 06/13.
The recall was initiated because certain lots of the product may not meet the dissolution specification for conjugated estrogens. This is a Class III recall, indicating that the violation is not likely to cause adverse health consequences.
Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed above. If the product matches the recalled description, it should be returned to the pharmacy or supplier for replacement or refund.
The recalled product
- Product
- Prempro (Conjugated Estrogen/Medroxyprogesterone Acetate) tablets 0.625 mg/2.5 mg, 1 blister card containing 28 tablets, Rx only, Wyeth Pharmaceuticals Inc., Philadelphia, PA, NDC 0046-0875-11
- Manufacturer
- Pfizer Inc.
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 432,657
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 (1)
- Lots: E67324 & E96152 Exp: 06/13
Distribution
Part of a larger recall action
This product is one of 2 recalled by Pfizer 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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