FDAFDA · Food and drugs·Recall number D-0078-2022
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
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
- Manufacturer
- MACLEODS PHARMA USA, INC
- Distributor
- Nationwide within the United States
- UPC
- 0333342088468
- Lot
- Lot #: BRJ2112A, BRJ2113A, BRJ2114A, BRJ2114B, exp. date 04/2024
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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