Class II · Moderate risk
Rizatriptan Benzoate Tablets
CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended acceptable intake limit.
Rizatriptan Benzoate Orally Disintegrating Tablets 10mg
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Out-of-specification test results obtained in Organic Impurities test during analysis of controlled samples.
Cause type: Impurity / degradation
An impurity or degradation product above its limit - other than nitrosamines. Unexpected substances in a batch can make it unsafe or less effective, even when the active ingredient is present. All impurity / degradation recalls.
What 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
Affected NDC
33342-0094-41
Compare with the code on your package — it is the most precise check available.
Drug: Rizatriptan
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| rizatriptan benzoate NDC 33342-0094 |
10 mg/1 | Tablet, Orally Disintegrating Oral |
Macleods Pharmaceuticals Limited | Rx |
- Recalling firm
- Macleods Pharma USA, INC
- NDC code
- 33342-094-41
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0080-2022 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Rizatriptan recalls
See all
Class II · Moderate risk
Rizatriptan Benzoate Tablets
CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended acceptable intake limit.
Class II · Moderate risk
Rizatriptan Benzoate Orally Disintegrating Tablets
CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.
Class II · Moderate risk
Rizatriptan Benzoate Orally Disintegrating Tablets
CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.
Class II · Moderate risk
Rizatriptan Benzoate Tablets USP
CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.
Other recalls by Macleods Pharma USA, INC
All 2021 recalls
Class II · Moderate risk
Levothyroxine Sodium Tablets USP 150 mcg
Subpotent Drug
Class II · Moderate risk
Losartan Potassium and Hydrochlorothiazide Tablets
Presence of foreign substance: plastic-like substance.
Class III · Low risk
Levofloxacin Tablets
Mismatching of the embossing on the tablets (T7) with the embossing mentioned in the package insert (ML63) in the distributed bottles.
Class II · Moderate risk
Eszopiclone Tablets
Shortfill: customer complaints of one to three tablets were reported missing from 30 count bottles.
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