FDA Drug recall D-0078-2022
Rizatriptan Benzoate Film Coated Tablets, 10 mg, packaged in a) 12 Tablets (2X6 Unit-Dose Tablets) Blister Packs, NDC 33342-088-45), b) 18…
- FDA Drug
- Class III
- terminated
- Published 2021-11-03
On 2021-11-03 the FDA classified a Class III recall of Rizatriptan Benzoate Film Coated Tablets, 10 mg, packaged in a) 12 Tablets (2X6 Unit-Dose Tablets) Blister Packs, NDC 33342-088-45), b) 18… 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-0078-2022 |
| 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 Film Coated Tablets, 10 mg, packaged in a) 12 Tablets (2X6 Unit-Dose Tablets) Blister Packs, NDC 33342-088-45), b) 18 Tablets (3 x 6 Unit-Dose Tablets, NDC 33342-088-41) Rx only, Manufactured for: Macleods Pharma USA, Inc. Plainsboro, NJ 08536l Manufactured by: Macleods Pharmaceuticals Ltd. Baddi, Himachal Pradesh, INDIA
Reason
Out-of-specification test results obtained in Organic Impurities test during analysis of controlled samples.
Identifiers
| ndc | 33342-087-07 |
|---|---|
| ndc | 33342-087-46 |
| ndc | 33342-087-12 |
| ndc | 33342-087-52 |
| ndc | 33342-087-50 |
| ndc | 33342-087-72 |
| ndc | 33342-087-02 |
| ndc | 33342-087-45 |
| ndc | 33342-087-41 |
| ndc | 33342-088-07 |
| ndc | 33342-088-46 |
| ndc | 33342-088-12 |
| ndc | 33342-088-52 |
| ndc | 33342-088-50 |
| ndc | 33342-088-72 |
| ndc | 33342-088-02 |
| ndc | 33342-088-45 |
| ndc | 33342-088-41 |
| code_info | Lot #: BRJ2112A, BRJ2113A, BRJ2114A, BRJ2114B, exp. date 04/2024 |
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-0078-2022%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.