Class II · Moderate risk
Corgard (nadolol tablets, USP)
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Nadolol Tablets
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Failed dissolution specification: recalled due to an out of specification dissolution result of 40% (Specification: NLT 80%)
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
Nadolol Tablets, USP, 40mg, packaged in 1000-count bottle, Rx Only, Manufactured by Sandoz Inc., Princeton, NJ 08540, NDC 0781-1182-10
Affected NDC
0781-1182-10
Compare with the code on your package — it is the most precise check available.
Drug: Nadolol
- Recalling firm
- Sandoz Incorporated
- NDC code
- 0781-1182-10
- Origin
- CO, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0236-2017 · 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 Nadolol recalls
See all
Class II · Moderate risk
Nadolol Tablets
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Nadolol 10 mg/1 mL Susp
Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.
Other recalls by Sandoz Incorporated
All 2016 recalls
Class III · Low risk
Triamterene and Hydrochlorothiazide Tablets
Cross Contamination With Other Products: presence of unrelated ingredients (i.e. traces of Lisinopril, Mannitol, Iron, Calcium and Phosphorous).
Class III · Low risk
Amitriptyline HCl Tablets
Cross Contamination With Other Product: Imipramine
Class III · Low risk
Fluoxetine Capsules USP
Labeling: Illegible Label: Sandoz Inc. is recalling of one lot of Fluoxetine Capsules due to an illegible logo on the capsule.
Class II · Moderate risk
Alprazolam Tablets
Presence of Foreign Substance; tablets may contain stainless steel metal particulates
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