Lacosamide 100mg Tablets Recalled Due to Foreign Tablet Contamination
Annora Pharma is recalling Lacosamide 100mg tablets nationwide after discovering Selexipag 1000 mcg tablets mixed into bottles. Patients taking the wrong medication could experience unintended health effects.
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: This is a Class II recall with potential for serious harm: contamination with a different active pharmaceutical ingredient (Selexipag, a pulmonary vasodilator) could cause patients to receive an unintended medication with significant adverse effects. Although no illnesses have been reported, the risk of harm is substantial because patients with seizure disorders taking Lacosamide could miss doses or receive an inappropriate drug.
Plain-English summary
Annora Pharma Private Limited is recalling Lacosamide Tablets USP, 100mg, distributed nationwide in the USA. A complaint was received indicating that Selexipag 1000 mcg tablets were found mixed in a bottle of Lacosamide Tablets USP, 100mg.
The affected product is Lacosamide Tablets, USP, C V, 100mg, Rx only, in 60-count bottles, manufactured by Annora Pharma Pvt., Ltd, Sangareddy, Telangana, India, and distributed by Camber Pharmaceuticals, Inc., Piscataway, NJ. The recalled lots are A253999 and A254000, which expire 09/30/2027. Approximately 31,392 bottles have been distributed.
Patients currently taking this medication should check their bottles for any tablets that do not match their expected appearance. If you find unfamiliar tablets, contact your pharmacy or healthcare provider immediately. Do not take any unknown tablets. Physicians and pharmacists should check inventory and quarantine affected lots.
For more information, contact Camber Pharmaceuticals, Inc., or visit the FDA's drug safety website.
The recalled product
- Product
- LACOSAMIDE (LACOSAMIDE)
- Brand
- LACOSAMIDE
- Manufacturer
- Annora Pharma Private Limited
- Hazard
- foreign-tablet-contamination
- wrong-medication
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 (3)
- Lot: A253999
- A254000
- Expires: 09/30/2027.
UPCs (4)
- 0331722815604
- 0331722813600
- 0331722814607
- 0331722812603
Distribution
Distributed nationwide across the United States.
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