Class III · Low risk
Eszopiclone Tablets
Failed Impurities/Degradation Specifications: Related Substances
Eszopiclone Tablets
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Shortfill: customer complaints of one to three tablets were reported missing from 30 count bottles.
Cause type: Failed specification
A physical or chemical test other than potency, dissolution, impurity or stability failed - pH, viscosity, appearance, tablet integrity, fill volume. A product outside its own specification may not perform as designed, even if the active ingredient is present. All failed specification recalls.
What was recalled
Eszopiclone Tablets, USP 1 mg, packaged in 30-count bottles, Rx Only, Manufactured for: Macleods Pharma USA, Inc., Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd., Baddi, Himachal Pradesh, INDIA, NDC 33342-299-07
Affected NDC
33342-0299-07
Compare with the code on your package — it is the most precise check available.
Drug: Eszopiclone
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 |
|---|---|---|---|---|
| Eszopiclone NDC 33342-0299 |
1 mg/1 | Tablet, Film Coated Oral |
Macleods Pharmaceuticals Limited | Rx · CIV |
- Recalling firm
- Macleods Pharma Usa Inc
- NDC code
- 33342-299-07
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1174-2022 · 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 Eszopiclone recalls
See all
Class II · Moderate risk
Eszopiclone 3mg 100 C4
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Eszopiclone
Labeling:Label Mixup; ESZOPICLONE, Tablet, 3 mg may be potentially mislabeled as CHOLECALCIFEROL, Tablet, 1000 units, NDC 00904582460, Pedigree: W002779, EXP: 6/6/2014.
Other recalls by Macleods Pharma Usa Inc
All 2022 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
Losartan potassium & Hydrochlorothiazide Tablets 100 mg/25 mg
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
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