Nitrofurantoin Oral Suspension USP, 25mg/5mL, 230 mL Bottle, Rx Only, Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202, UPC 343386-450-114, NDC 43386-450-11
Reported: July 18, 2018 Initiated: June 28, 2018 #D-0927-2018
Product Description
Nitrofurantoin Oral Suspension USP, 25mg/5mL, 230 mL Bottle, Rx Only, Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202, UPC 343386-450-114, NDC 43386-450-11
Reason for Recall
Subpotent Drug and Failed Content Uniformity.
Details
- Recalling Firm
- LUPIN SOMERSET
- Units Affected
- 3456 cartons
- Distribution
- Nationwide within the US
- Location
- Somerset, NJ
Frequently Asked Questions
What product was recalled? ▼
Nitrofurantoin Oral Suspension USP, 25mg/5mL, 230 mL Bottle, Rx Only, Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202, UPC 343386-450-114, NDC 43386-450-11. Recalled by LUPIN SOMERSET. Units affected: 3456 cartons.
Why was this product recalled? ▼
Subpotent Drug and Failed Content Uniformity.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 18, 2018. Severity: Moderate. Recall number: D-0927-2018.
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