Rizatriptan Tablet, Film Coated
FDA Recall NDC 33342-088
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Rizatriptan (NDC 33342-088). A significant event, classified as Class III, was initiated on Oct 18, 2021 by Macleods Pharmaceuticals Limited. The reported reason for this action was: "Out-of-specification test results obtained in Organic Impurities test during analysis of controlled samples."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
October 2021 Class III Recall: Out-of-specification test results obtained in Organic Impurities test during analysis of controlled samples.
Recall Number
Class III Terminated
Out-of-specification test results obtained in Organic Impurities test during analysis of controlled samples.
Oct 18, 2021
Nov 03, 2021
135,082 Blister Packs/2,431,476 tablets
Recall Profile & Regulatory Data
Event ID
88872
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
MACLEODS PHARMA USA, INC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States
Termination Date
Apr 24, 2024
Product Description
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
Batch or Lot Expiration Information
Lot# : BRJ2112A, BRJ2113A, BRJ2114A, BRJ2114B, exp. date 04/2024
Affected Packages Involved in this Recall
33342-087-07Product
33342-087-46Product
33342-087-12Product
33342-087-52Product
33342-087-50Product
33342-087-72Product
33342-087-02Product
33342-087-45Product
33342-087-41Product
33342-088-07Product
33342-088-46Product
33342-088-12Product
33342-088-52Product
33342-088-50Product
33342-088-72Product
33342-088-02Product
33342-088-45Product
33342-088-41Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
