Class II · Moderate risk
Bisoprolol Fumarate tablets
Failed Impurities/Degradation Specifications: Out of Specification for an unknown impurity was observed during the 18 month stability testing.
National Drug Code
Is NDC 29300-0126-13 recalled?
Bisoprolol Fumarate · 30 TABLET in 1 BOTTLE, PLASTIC (29300-126-13)
Yes — this exact package was recalled
1 FDA recall names the code 29300-0126-13 directly. A recall still applies to particular lot numbers — compare the lot on your package with the FDA notice below, and talk to your pharmacist before stopping a prescribed medication.
- Active ingredient
- Bisoprolol fumarate
- Strength
- BISOPROLOL FUMARATE 5 mg/1
- Form
- Tablet · Oral
- Labeler
- Unichem Pharmaceuticals (USA), Inc.
- Type
- Human Prescription Drug
- Product code
- 29300-0126
Recalls naming this package
Class II · Moderate risk
BISOPROLOL FUMARATE Tablet
Labeling: Label Mixup; BISOPROLOL FUMARATE Tablet, 5 mg may be potentially mislabeled as: ESTROPIPATE, Tablet, 0.75 mg, NDC 00591041401, Pedigree: AD34934_4, EXP: 5/10/2014.
Where to find this code. The NDC is printed on the pharmacy label and on the manufacturer's carton, usually as three groups of digits after “NDC”. The last group is the package size — two bottles of the same medicine can differ only in that group, and a recall may cover one but not the other.
Other recalled products from this labeler
- 29300-0128 Hydrochlorothiazide 2
- 29300-0135 See recall 2
- 29300-0113 Lamotrigine 1
- 29300-0116 topiramate 1
- 29300-0137 clonidine hydrochloride 1
- 29300-0140 Divalproex Sodium 1
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