Class II · Moderate risk
Nitrofurantoin Monohydrate/Macrycrystals Capsules
Failed dissolution specifications
National Drug Code
Is NDC 47781-0303-01 recalled?
Nitrofurantoin Monohydrate/ Macrocrystalline · 100 CAPSULE in 1 BOTTLE (47781-303-01)
Yes — this exact package was recalled
3 FDA recalls name the code 47781-0303-01 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
- Nitrofurantoin Monohydrate/Macrocrystalline
- Strength
- NITROFURANTOIN 25 mg/1; NITROFURANTOIN MONOHYDRATE 75 mg/1
- Form
- Capsule · Oral
- Labeler
- Alvogen Inc.
- Type
- Human Prescription Drug
- Product code
- 47781-0303
Recalls naming this package
Class II · Moderate risk
Nitrofurantoin Monohydrate/Macrocrystals Capsules
Failed Dissolution Specification; 6 month time point
Class II · Moderate risk
NITROFURANTOIN MONOHYDRATE/ MACROCRYSTALS Capsule
Labeling: Label Mixup; NITROFURANTOIN MONOHYDRATE/ MACROCRYSTALS, Capsule, 100 mg may be potentially mislabeled as MINOCYCLINE HCL, Capsule, 50 mg, NDC 00591569401, Pedigree: AD52778_46, EXP: 5/20/2014.
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
- 47781-0304 See recall 1
- 47781-0306 See recall 1
- 47781-0307 See recall 1
- 47781-0355 Buprenorphine and Naloxone Sublingual Film 1
- 47781-0356 Buprenorphine and Naloxone Sublingual Film 1
- 47781-0368 See recall 1
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