Recall: D-0079-2022

Class III - Minor Violations

Class IIIClassification

2021-10-18Initiated

TerminatedStatus

MACLEODS PHARMA USA, INCFirm

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

Reason

Out-of-specification test results obtained in Organic Impurities test during analysis of controlled samples.

Distribution

Nationwide within the United States

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.