Mylan Recalls Lansoprazole Capsules Due to Foreign Topiramate Tablets
Mylan Pharmaceuticals is recalling 1,894 bottles of lansoprazole 30 mg capsules because they may contain foreign topiramate 100 mg tablets.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. According to the rubric, FDA Class II recalls with potential for significant injury or adverse health consequences (such as receiving the wrong medication) are classified as Severe (Score 4).
Plain-English summary
Mylan Pharmaceuticals Inc. is recalling 1,894 bottles of Lansoprazole Delayed-release Capsules, USP, 30 mg. The recall is due to the presence of foreign topiramate 100 mg tablets in the bottles. The affected product is identified by Lot # 1110829 and an expiration date of 05/14. The product was distributed nationwide.
Lansoprazole is a prescription medication used to inhibit gastric acid secretion. The presence of topiramate tablets in a lansoprazole bottle poses a risk of patients receiving an unintended medication. Topiramate is a different drug with distinct therapeutic uses and potential side effects.
Consumers who have purchased this specific lot of lansoprazole should stop using it and contact their healthcare provider or pharmacist for guidance. The recall is classified as FDA Class II, indicating a reasonable probability that use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- LANSOPRAZOLE (LANSOPRAZOLE)
- Brand
- LANSOPRAZOLE
- Manufacturer
- Mylan Pharmaceuticals Inc.
- Category
- Drug — Prescription Medication
- Affected units
- 1,894
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 #: 1110829
- Exp 05/14
UPCs (2)
- 0303788030932
- 0303788015939
Distribution
Distributed nationwide across the United States.
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