FDAFDA · Food and drugs·Recall number D-0080-2022
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
Published November 3, 2021 · Recall initiated: October 18, 2021
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Out-of-specification test results obtained in Organic Impurities test during analysis of controlled samples.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- RIZATRIPTAN BENZOATE
- Manufacturer
- MACLEODS PHARMA USA, INC
- Distributor
- Nationwide within the United States
- UPC
- 0333342094452
- Lot
- Lot #: BRM2111A, BRM2112A, BRM2113A, BRM2114A, BRM2115A, BRM2116A, exp. date 04/2025
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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