Class I · High risk
Atenolol Tablets
Label Mix - up; a bottle labeled as Atenolol 25mg Tablets contained Clopidogrel 75mg Tablets
ATENOLOL Tablets
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Presence of Foreign Tablets/Capsules: Customer complaint that a bottle of atenolol 50 mg Tablets USP contained a paroxetine 20 mg tablet.
Cause type: Particulate / foreign matter
Visible foreign particles - glass, metal, fibers or other material - found in the product. Particles can enter from equipment wear, containers or the process, and are dangerous in injectables. All particulate / foreign matter recalls.
What was recalled
ATENOLOL Tablets, USP, 50 mg, 30-count bottle, Rx only, Distributed by: The Kroger Co., 1014 Vine Street, Cincinnati, OH 45202; Manufactured for: Zydus Pharmaceuticals USA Inc., Pennington, NJ 08534; Packaged by: Legacy Pharmaceutical Packaging LLC, Earth City, MO 63045; NDC 68645-493-54.
Affected NDC
68645-0493-54
Compare with the code on your package — it is the most precise check available.
Drug: Atenolol Category: Blood Pressure Medication
- Recalling firm
- Legacy Pharmaceutical Packaging LLC
- NDC code
- 68645-493-54
- Origin
- MO, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0606-2017 · 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 Atenolol recalls
See all
Class II · Moderate risk
ATENOLOL Tablets
Presence of Foreign Tablets/Capsules: Customer complaint that a bottle of atenolol 50 mg Tablets USP contained a paroxetine 20 mg tablet.
Class II · Moderate risk
ZyGenerics ATENOLOL Tablets
Superpotent Drug: A complaint was reported by a pharmacist who stated several tablets were noticeably thicker in appearance.
Class II · Moderate risk
ATENOLOL Tablet
Labeling:Label Mixup; ATENOLOL, Tablet, 12.5 mg (1/2 of 25 mg) may be potentially mislabeled as VITAMIN B COMPLEX WITH C/FOLIC ACID, Tablet, NDC 60258016001, Pedigree: AD73652_19, EXP: 5/30/2014; PIROXICAM, Capsule, 10 mg, NDC 00093075601, Pedigree: AD21836_1, EXP: 3/31/2014.
Other recalls by Legacy Pharmaceutical Packaging LLC
All 2017 recalls
Class II · Moderate risk
Sertraline Tablets
CGMP Deviations: Inadequate line clearance which may result in a potential comingling of product.
Class III · Low risk
Metformin Hydrochloride Tablets USP
Presence of Foreign Tablets/Capsules: Metformin 1000mg with different imprint was found in bottles.
Class II · Moderate risk
Losartan Potassium Tablets
CGMP Deviations: Detection of trace amounts of N-Methylnitrosobutyric acid (NMBA) impurity found in the Active Pharmaceutical Ingredient (API)
Class II · Moderate risk
Losartan Potassium Tablets
CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) detected.
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