Class II · Moderate risk
Rasagiline Mesylate Tablets 1 mg
Presence of Foreign Substance- A complaint was received of black spots/shiny metallic speck on the tablets.
Rasagiline Tablets 0.5mg
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Failed dissolution specifications - results obtained were below spec average.
Cause type: Dissolution failure
The tablet or capsule did not dissolve within specification. Dissolution controls how much drug the body absorbs; a failure can change the effective dose. All dissolution failure recalls.
What was recalled
Rasagiline Tablets 0.5mg, 30-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A., NDC 0378-1270-93
Affected NDC
0378-1270-93
Compare with the code on your package — it is the most precise check available.
Drug: Rasagiline
- Recalling firm
- Aurobindo Pharma USA Inc.
- NDC code
- 0378-1270-93
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1171-2023 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Rasagiline recalls
See all
Class II · Moderate risk
Rasagiline Mesylate
Labeling:Label Mixup; RASAGILINE MESYLATE, Tablet, 0.5 mg may be potentially mislabeled as OMEGA-3 FATTY ACID, Capsule, 1000 mg, NDC 40985022921, Pedigree: W002690, EXP: 6/5/2014.
Other recalls by Aurobindo Pharma USA Inc.
All 2023 recalls
Class II · Moderate risk
Dicyclomine Hydrochloride Capsules
shortfill; reports of empty capsules.
Class II · Moderate risk
Acetaminophen Tablets
cGMP deviations: Due to confirmed consumer complaints received with the observation of tablet discoloration (brown surface on tablets).
Class II · Moderate risk
Nebivolol Tablets
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso Nebivolol above acceptable intake (AI) limit.
Class II · Moderate risk
Cinacalcet Tablets
cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
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