FDA DrugsClass II
Lacosamide Tablets, USP, C V, 100mg, Rx only, 60-count bottle, By: Annora Pharma...
Published: July 1, 2026Recall ID: D-0626-2026Category: drugsCountry: US
Reason for Recall / Hazard
Presence of a Foreign Tablets: Complaint received, possible mix-up of Selexipag 1000 mcg tablet in a bottle of Lacosamide Tablets USP, 100mg.
Product Description & Identification
Lacosamide Tablets, USP, C V, 100mg, Rx only, 60-count bottle, By: Annora Pharma Pvt., Ltd, Sangareddy -502313, Telangana, India, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, NDC 31722-813-60.
Additional Source Details
| Field | Value |
|---|---|
| City | Hyderabad |
| State | N/A |
| Openfda › Nui | N0000008486 |
| Openfda › Upc › 1 | 0331722815604 |
| Openfda › Upc › 2 | 0331722813600 |
| Openfda › Upc › 3 | 0331722814607 |
| Openfda › Upc › 4 | 0331722812603 |
| Openfda › Unii | 563KS2PQY5 |
| Openfda › Route | ORAL |
| Openfda › Rxcui › 1 | 809987 |
| Openfda › Rxcui › 2 | 809992 |
| Openfda › Rxcui › 3 | 809996 |
| Openfda › Rxcui › 4 | 810000 |
| Openfda › Spl id | 54d629b7-e234-69f1-e063-6294a90ab0e7 |
| Openfda › Brand name | LACOSAMIDE |
| Openfda › Spl set id | c5b91128-f838-4e98-9684-5f477fc7af06 |
| Openfda › Package ndc › 1 | 31722-812-60 |
| Openfda › Package ndc › 2 | 31722-812-18 |
| Openfda › Package ndc › 3 | 31722-812-05 |
| Openfda › Package ndc › 4 | 31722-812-32 |
| Openfda › Package ndc › 5 | 31722-813-60 |
| Openfda › Package ndc › 6 | 31722-813-18 |
| Openfda › Package ndc › 7 | 31722-813-05 |
| Openfda › Package ndc › 8 | 31722-813-32 |
| Openfda › Package ndc › 9 | 31722-814-60 |
| Openfda › Package ndc › 10 | 31722-814-18 |
| Openfda › Package ndc › 11 | 31722-814-05 |
| Openfda › Package ndc › 12 | 31722-814-32 |
| Openfda › Package ndc › 13 | 31722-815-60 |
| Openfda › Package ndc › 14 | 31722-815-18 |
| Openfda › Package ndc › 15 | 31722-815-05 |
| Openfda › Package ndc › 16 | 31722-815-32 |
| Openfda › Product ndc › 1 | 31722-812 |
| Openfda › Product ndc › 2 | 31722-813 |
| Openfda › Product ndc › 3 | 31722-814 |
| Openfda › Product ndc › 4 | 31722-815 |
| Openfda › Generic name | LACOSAMIDE |
| Openfda › Product type | HUMAN PRESCRIPTION DRUG |
| Openfda › Pharm class pe | Decreased Central Nervous System Disorganized Electrical Activity [PE] |
| Openfda › Substance name | LACOSAMIDE |
| Openfda › Manufacturer name | Camber Pharmaceuticals, Inc. |
| Openfda › Application number | ANDA204787 |
| Openfda › Is original packager | true |
| Event id | 99200 |
| Address 1 | Sy. No.261, Plot No. 13 And 14, Annaram Village, Gummadidal Mandal |
| Address 2 | Jinnaram Mandal, Sangareddy District, Medak |
| Code info | Lot: A253999, A254000, Expires: 09/30/2027. |
| Postal code | N/A |
| Report date | 20260701 |
| Product type | Drugs |
| Product quantity | 31,392 60-count bottles |
| Reason for recall | Presence of a Foreign Tablets: Complaint received, possible mix-up of Selexipag 1000 mcg tablet in a bottle of Lacosamide Tablets USP, 100mg. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260604 |
| Initial firm notification | |
| Center classification date | 20260625 |
Overview
- Recalling FirmAnnora Pharma Private Limited
- StatusOngoing
- Risk LevelClass II
- DistributionNationwide in the USA