Rizatriptan Benzoate Tablet, Orally Disintegrating
FDA Recall NDC 33342-094
Latest: Class III · Status: Terminated · Initiated Oct 18, 2021 · 2 enforcement reports
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Rizatriptan Benzoate (NDC 33342-094). 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
13,260 Blister Packs/238,680 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 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
Batch or Lot Expiration Information
Lot# : BRL2102A, BRL2103A, exp. date 04/2025
Affected Packages Involved in this Recall
33342-093-48Rizatriptan Benzoate
33342-093-07Rizatriptan Benzoate
33342-093-46Rizatriptan Benzoate
33342-093-12Rizatriptan Benzoate
33342-093-52Rizatriptan Benzoate
33342-093-73Rizatriptan Benzoate
33342-093-72Rizatriptan Benzoate
33342-093-41Rizatriptan Benzoate
33342-093-45Rizatriptan Benzoate
33342-093-04Rizatriptan Benzoate
33342-093-23Rizatriptan Benzoate
33342-094-47Rizatriptan Benzoate
33342-094-07Rizatriptan Benzoate
33342-094-46Rizatriptan Benzoate
33342-094-12Rizatriptan Benzoate
33342-094-52Rizatriptan Benzoate
33342-094-73Rizatriptan Benzoate
33342-094-72Rizatriptan Benzoate
33342-094-41Rizatriptan Benzoate
33342-094-45Rizatriptan Benzoate
33342-094-04Rizatriptan Benzoate
33342-094-23Rizatriptan Benzoate
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
643,800 Blister Packs /888,336 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 Orally Disintegrating Tablets 10mg, 18 Tablets (3 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 33342-094-41
Batch or Lot Expiration Information
Lot# : BRM2111A, BRM2112A, BRM2113A, BRM2114A, BRM2115A, BRM2116A, exp. date 04/2025
Affected Packages Involved in this Recall
33342-093-48Rizatriptan Benzoate
33342-093-07Rizatriptan Benzoate
33342-093-46Rizatriptan Benzoate
33342-093-12Rizatriptan Benzoate
33342-093-52Rizatriptan Benzoate
33342-093-73Rizatriptan Benzoate
33342-093-72Rizatriptan Benzoate
33342-093-41Rizatriptan Benzoate
33342-093-45Rizatriptan Benzoate
33342-093-04Rizatriptan Benzoate
33342-093-23Rizatriptan Benzoate
33342-094-47Rizatriptan Benzoate
33342-094-07Rizatriptan Benzoate
33342-094-46Rizatriptan Benzoate
33342-094-12Rizatriptan Benzoate
33342-094-52Rizatriptan Benzoate
33342-094-73Rizatriptan Benzoate
33342-094-72Rizatriptan Benzoate
33342-094-41Rizatriptan Benzoate
33342-094-45Rizatriptan Benzoate
33342-094-04Rizatriptan Benzoate
33342-094-23Rizatriptan Benzoate
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.
