FDA Drug recall D-0079-2022
Rizatriptan Benzoate Orally Disintegrating Tablets 5mg, 12 Tablets (2 x 6 Unit-Dose Tablets) Blister Packs, Rx only, Manufactured for: Macl…
- FDA Drug
- Class III
- terminated
- Published 2021-11-03
On 2021-11-03 the FDA classified a Class III recall of Rizatriptan Benzoate Orally Disintegrating Tablets 5mg, 12 Tablets (2 x 6 Unit-Dose Tablets) Blister Packs, Rx only, Manufactured for: Macl… by Macleods Pharma Usa, citing out-of-specification test results obtained in Organic Impurities test during analysis of controlled samples.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0079-2022 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2021-10-18 |
| Published | 2021-11-03 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Macleods Pharma Usa |
| Distribution | US |
Product
Rizatriptan Benzoate Orally Disintegrating Tablets 5mg, 12 Tablets (2 x 6 Unit-Dose Tablets) Blister Packs, Rx only, Manufactured for: Macleods Pharma USA Inc. Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd. Baddi, Himachal Pradesh, INDIA, NDC 33342-093-41
Reason
Out-of-specification test results obtained in Organic Impurities test during analysis of controlled samples.
Identifiers
| ndc | 33342-093-48 |
|---|---|
| ndc | 33342-093-07 |
| ndc | 33342-093-46 |
| ndc | 33342-093-12 |
| ndc | 33342-093-52 |
| ndc | 33342-093-73 |
| ndc | 33342-093-72 |
| ndc | 33342-093-41 |
| ndc | 33342-093-45 |
| ndc | 33342-093-04 |
| ndc | 33342-093-23 |
| ndc | 33342-094-47 |
| ndc | 33342-094-07 |
| ndc | 33342-094-46 |
| ndc | 33342-094-12 |
| ndc | 33342-094-52 |
| ndc | 33342-094-73 |
| ndc | 33342-094-72 |
| ndc | 33342-094-41 |
| ndc | 33342-094-45 |
| ndc | 33342-094-04 |
| ndc | 33342-094-23 |
| code_info | Lot #: BRL2102A, BRL2103A, exp. date 04/2025 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0079-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.