🔍 RecallPedia

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

Class I - Dangerous
💊 Drugs Recalled: October 18, 2021 MACLEODS PHARMA USA Prescription Drugs Nationwide

What Should You Do?

  1. Check if you have this product:
    Lot #: BRM2111A, BRM2112A, BRM2113A, BRM2114A, BRM2115A, BRM2116A, exp. date 04/2025
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
MACLEODS PHARMA USA, INC
Reason for Recall:
Out-of-specification test results obtained in Organic Impurities test during analysis of controlled samples.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full 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

Product Codes/Lot Numbers:

Lot #: BRM2111A, BRM2112A, BRM2113A, BRM2114A, BRM2115A, BRM2116A, exp. date 04/2025

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-0080-2022

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