Reported Nov 3, 2021 · Terminated
Rizatriptan Benzoate Film Coated Tablets, 10 mg, packaged in a) 12 Tablets (2X6 Unit-Dose Tablets) Blister Packs, NDC…
Macleods Pharma USA, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: MACLEODS PHARMA USA, INC · 103 College Rd E Fl 2 · Princeton, NJ · 08540-6611
Is this the product you have?
- 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 forMacleods Pharma USA, Inc. Plainsboro
- NJ 08536l Manufactured byMacleods Pharmaceuticals Ltd. Baddi, Himachal Pradesh, INDIA
- Lot codes and dates
Lot #: BRJ2112ABRJ2113ABRJ2114ABRJ2114Bexp. date 04/2024
- Amount recalled
- 135,082 Blister Packs/2,431,476 tablets
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was recalled
Out-of-specification test results obtained in Organic Impurities test during analysis of controlled samples.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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