Pfizer Recalls Cytotec Tablets Due to Failed Impurity Specifications
Pfizer is recalling 1,706 cartons of Cytotec (misoprostol) tablets nationwide because the product failed impurity and degradation specifications.
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 FDA classified this as a Class III recall, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.
Plain-English summary
Pfizer Inc. is recalling 1,706 cartons of Cytotec (misoprostol) 200 mcg tablets, 100-tablet blister packs, distributed nationwide. The recall involves Lot # B08493 (Expiration Date 12/2016) and Lot # B13230 (Expiration Date 08/2018). The product is for in-institution use only and is a prescription-only medication.
The recall was initiated because the product failed impurities and degradations specifications. Specifically, there were out-of-specification results for two known degradation products and total impurities at 18 months. The U.S. Food and Drug Administration has classified this as a Class III recall, which indicates that there is a remote possibility that the use of or exposure to the violative product may cause temporary or medically reversible adverse health consequences, or that the probability of serious adverse health consequences is remote.
Healthcare facilities and institutions that have received these specific lots of Cytotec should stop using the product and contact Pfizer for instructions on return or disposal. Consumers should not use the recalled product and should consult their healthcare provider if they have questions regarding their medication.
The recalled product
- Product
- CYTOTEC (MISOPROSTOL)
- Brand
- CYTOTEC
- Manufacturer
- Pfizer Inc.
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 1,706
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)
- 1) Lot # B08493 - Expiration Date 12/2016
- 2) Lot # B13230 - Expiration Date 08/2018
UPCs (1)
- 0300251461606
Distribution
Distributed nationwide across the United States.
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