Reported Nov 3, 2021 · Terminated
Rizatriptan Benzoate Orally Disintegrating Tablets 10mg, 18 Tablets (3 x 6 Unit-Dose Tablets) Blister Packs, Rx only,…
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 Orally Disintegrating Tablets 10mg, 18 Tablets (3 x 6 Unit-Dose Tablets) Blister Packs, Rx only
- Manufactured forMacleods Pharma USA Inc. Plainsboro, NJ 08536
- Manufactured byMacleods Pharmaceuticals Ltd. Baddi, Himachal Pradesh, INDIA, NDC 33342-094-41
- Lot codes and dates
Lot #: BRM2111ABRM2112ABRM2113ABRM2114ABRM2115ABRM2116Aexp. date 04/2025
- Amount recalled
- 643,800 Blister Packs /888,336 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.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Macleods Pharma USA, Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.