Class II · Moderate risk
Quinapril Tablets USP
CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.
Quinapril Tablets USP
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.
Cause type: Nitrosamine impurity
Trace nitrosamine impurities such as NDMA, NDEA or NMBA found above the acceptable daily limit. Nitrosamines are probable human carcinogens that can form during manufacturing or storage. This is the cause behind the large valsartan, losartan and ranitidine (Zantac) recalls. All nitrosamine impurity recalls.
What was recalled
Quinapril Tablets USP, 20 mg (90 pack), Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, by: Lupin Limited, Goa 403 722 India, NDC# 68180-558-09
Affected NDC
68180-0558-09
Compare with the code on your package — it is the most precise check available.
Drug: Quinapril
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 |
|---|---|---|---|---|
| Quinapril NDC 68180-0558 |
HYDROCHLORIDE 20 mg/1 | Tablet Oral |
Lupin Pharmaceuticals, Inc. | Rx |
- Recalling firm
- Lupin Pharmaceuticals Inc.
- NDC code
- 68180-558-09
- Origin
- MD, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0089-2023 · 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 Quinapril recalls
See all
Class II · Moderate risk
Quinapril and Hydrochlorothiazide Tablets
CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.
Class II · Moderate risk
Accupril (Quinapril HCl Tablets)
CGMP Deviations: Contains N-nitrosoquinapril above the acceptable limits.
Class II · Moderate risk
Accupril (Quinapril HCl Tablets)
CGMP Deviations: Contains N-nitrosoquinapril above the acceptable limits.
Class II · Moderate risk
Accupril (Quinapril HCl Tablets)
CGMP Deviations: Contains N-nitrosoquinapril above the acceptable limits.
Other recalls by Lupin Pharmaceuticals Inc.
All 2022 recalls
Class II · Moderate risk
Clobetasol Propionate Cream USP
Failed content uniformity specifications.
Class II · Moderate risk
Glucagon Emergency Kit for Low Blood Sugar
CGMP deviation: OOS result observed for the Gliding Force functionality test during 12-month long term stability testing.
Class II · Moderate risk
prednisoLONE Acetate Ophthalmic Suspension
Presence of Foreign Substance
Class II · Moderate risk
Liraglutide Injection
Presence of particulate matter: a white thread-like structure in the cartridge
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