Multi-event October 2021 FDA Recall Rizatriptan by Macleods Pharma Usa, Inc
This Multi-event Class III drug recall was voluntarily initiated by Macleods Pharma Usa, Inc on October 18, 2021 for the product Rizatriptan. The FDA reported the reason for recall as out-of-specification test results obtained in organic impurities test during analysis of controlled samples.. The product was distributed Nationwide and the recall is currently terminated.
Reported Recall Events
Recall Number: D-0079-2022
Out-of-specification test results obtained in Organic Impurities test during analysis of controlled samples.
10-18-2021
11-03-2021
13,260 Blister Packs/238,680 tablets
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
MACLEODS PHARMA USA, INC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide within the United States
04-24-2024
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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
Batch or Lot Expiration Information
Lot# : BRL2102A, BRL2103A, exp. date 04/2025
Affected Packages Involved in this Recall
Recall Number: D-0080-2022
Out-of-specification test results obtained in Organic Impurities test during analysis of controlled samples.
10-18-2021
11-03-2021
643,800 Blister Packs /888,336 Tablets
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
MACLEODS PHARMA USA, INC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide within the United States
04-24-2024
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
Recall Number: D-0078-2022
Out-of-specification test results obtained in Organic Impurities test during analysis of controlled samples.
10-18-2021
11-03-2021
135,082 Blister Packs/2,431,476 tablets
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
MACLEODS PHARMA USA, INC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide within the United States
04-24-2024
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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
Batch or Lot Expiration Information
Lot# : BRJ2112A, BRJ2113A, BRJ2114A, BRJ2114B, exp. date 04/2024
