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 for: Macleods Pharma USA, Inc. Plainsboro, NJ 08536l Manufactured by: Macleods Pharmaceuticals Ltd. Baddi, Himachal Pradesh, INDIA
Reported: November 3, 2021 Initiated: October 18, 2021 #D-0078-2022
Product Description
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 for: Macleods Pharma USA, Inc. Plainsboro, NJ 08536l Manufactured by: Macleods Pharmaceuticals Ltd. Baddi, Himachal Pradesh, INDIA
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
- 135,082 Blister Packs/2,431,476 tablets
- Distribution
- Nationwide within the United States
- Location
- Princeton, NJ
Frequently Asked Questions
What product was recalled? ▼
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 for: Macleods Pharma USA, Inc. Plainsboro, NJ 08536l Manufactured by: Macleods Pharmaceuticals Ltd. Baddi, Himachal Pradesh, INDIA. Recalled by MACLEODS PHARMA USA, INC. Units affected: 135,082 Blister Packs/2,431,476 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-0078-2022.
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