FDA-Drug2021-11-03Class III
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
MACLEODS PHARMA USA, INC
Hazard
Out-of-specification test results obtained in Organic Impurities test during analysis of controlled samples.
Sold states
Nationwide within the United States
Affected count
13,260 Blister Packs/238,680 tablets
Manufactured in
103 College Rd E Fl 2, N/A, Princeton, NJ, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0079-2022Don't want to check this manually?
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