Class II
Terminated
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.
- Company
- Lupin Somerset
- Recall Initiated
- December 21, 2018
- Posted
- January 9, 2019
- Recall Number
- D-0346-2019
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 23,460 bottles
- Firm Location
- Somerset, NJ, United States
Reason for Recall
Subpotent Drug: Expansion of June 2018 recall of lots S700065 and S700619 due to below specification results for assay.
Distribution
Nationwide in the USA and Puerto Rico.
Lot / Code Info
Lot #: S700038, S700044, S700059, S700065, Exp 28-Feb-19; S700410, S700427, Exp 30-Jun-19; S700617, S700619, Exp 31-Aug-19; S700813, S700815, S700869, Exp 31-Oct-19; S700871, S700873, Exp 30-Nov-19; S700875, S701073, Exp 31-Dec-19.
More recalls by Lupin Somerset
Morphine Sulfate Extended-Release Tablets, 60 mg, 100-count bottles, Rx Only, Manufactured by: Novel...
May 1, 2019 · Class III
Gavilyte-N, PEG-3350, Sodium chloride, Sodium Bicarbonate and Potassium Chloride for Oral Solution,...
Apr 17, 2019 · Class II
Fluocinolone Acetonide Topical Solution, USP, 0.01 %, 60 mL bottle, Rx Only, Manufactured for: Lupin...
Jan 30, 2019 · Class II
Other recent Class II Drug recalls
Vista Tears Polyethylene Glycol 400 0.4% w/v, Propylene Glycol 0.3% w/v Eye Drops, Dry Eye Relief, L...
Wizcure Pharmaa Private Limited
· Mar 4, 2026
Amantadine HCl, Capsules, UPS, 100 mg, 50 Capsules (5 x 10) unit dose, Rx Only, Manufactured for: Av...
Avkare
· Mar 4, 2026
Agebox iKids-Growth (Day Formula) capsules, 60-count bottles, Manufactured Exclusively For: AGEBOX I...
Agebox
· Mar 4, 2026
Adbry, (tralokinumab-ldrm) injection, 300 mg/2mL, Packaged as a) 1 x Single dose Autoinjector, SAMPL...
Leo Pharma Inc
· Mar 4, 2026
Pro Numb Tattoo Numbing Spray, For Sensitive Skin, 4% Lidocaine, [1FL OZ/28.4 ML or 4 oz/120 mL] per...
Pro Numb Tattoo Numbing Spray Llc
· Feb 18, 2026