Eywa Pharma Recalls Levetiracetam Tablets Due to Foreign Tablet Presence
Eywa Pharma Inc. is recalling 500 mg Levetiracetam tablets because a 1000 mg tablet was found in a 500 mg bottle.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (foreign object in medication) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Eywa Pharma Inc. is recalling Levetiracetam Tablets, USP 500 mg, packaged in 120-count bottles. The recall is due to the presence of a foreign tablet, specifically a 1000 mg Levetiracetam tablet, found in a 500 mg bottle.
The affected product is identified by Lot # LEV5019021A with an expiration date of 10/2021. A total of 5,451 bottles were distributed nationwide in the United States. The product is manufactured by VKT Pharma Private Limited in India for Eywa Pharma Inc.
Consumers should check their medication for the specific lot number and expiration date listed above. If the product matches the recalled lot, patients should stop using it and contact their healthcare provider or pharmacist for guidance on obtaining a replacement.
The recalled product
- Product
- Levetiracetam Tablets, USP 500 mg, packaged in 120-count bottle, Rx only, Manufactured by: VKT Pharma Private Limited Srikakulam, India - 532 409, Manufactured for: Eywa Pharma Inc. 2 Research Way, Floor 3 Princeton, NJ 08540, NDC 71930-063-52
- Manufacturer
- EYWA PHARMA INC
- Category
- Drug — Prescription Medication
- Affected units
- 5,451
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 #: LEV5019021A
- Exp 10/2021
Distribution
Distributed nationwide across the United States.
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