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, NDC 43386-450-11.
Reported: January 9, 2019 Initiated: December 21, 2018 #D-0346-2019
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, NDC 43386-450-11.
Reason for Recall
Subpotent Drug: Expansion of June 2018 recall of lots S700065 and S700619 due to below specification results for assay.
Details
- Recalling Firm
- LUPIN SOMERSET
- Units Affected
- 23,460 bottles
- Distribution
- Nationwide in the USA and Puerto Rico.
- 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, NDC 43386-450-11.. Recalled by LUPIN SOMERSET. Units affected: 23,460 bottles.
Why was this product recalled? ▼
Subpotent Drug: Expansion of June 2018 recall of lots S700065 and S700619 due to below specification results for assay.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on January 9, 2019. Severity: Moderate. Recall number: D-0346-2019.
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