Rizatriptan Benzoate Orally Disintegrating Tablets 10mg, 18 Tablets (3 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 33342-094-41
Reported: November 3, 2021 Initiated: October 18, 2021 #D-0080-2022
Product Description
Rizatriptan Benzoate Orally Disintegrating Tablets 10mg, 18 Tablets (3 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 33342-094-41
Reason for Recall
Out-of-specification test results obtained in Organic Impurities test during analysis of controlled samples.
Details
- Recalling Firm
- MACLEODS PHARMA USA, INC
- Units Affected
- 643,800 Blister Packs /888,336 Tablets
- Distribution
- Nationwide within the United States
- Location
- Princeton, NJ
Frequently Asked Questions
What product was recalled? ▼
Rizatriptan Benzoate Orally Disintegrating Tablets 10mg, 18 Tablets (3 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 33342-094-41. Recalled by MACLEODS PHARMA USA, INC. Units affected: 643,800 Blister Packs /888,336 Tablets.
Why was this product recalled? ▼
Out-of-specification test results obtained in Organic Impurities test during analysis of controlled samples.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on November 3, 2021. Severity: Low. Recall number: D-0080-2022.
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