Class II
Terminated
Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg Inhalation Solution, packaged in 30x3 mL Sterile Unit-Dose Vials, a) 30 count (NDC 0487-0201-03) and b) 60 count (NDC 0487-0201-60) vials per carton, Rx only, Nephron Pharmaceutical Corporation, Orlando, FL
This recall has been terminated (originally issued October 21, 2015).
- Company
- Nephron Pharmaceuticals Corp.
- Recall Initiated
- August 21, 2015
- Posted
- October 21, 2015
- Recall Number
- D-0010-2016
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- a) 85,248 cartons and b) 35,292 cartons
- Firm Location
- Orlando, FL, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Lack of Assurance of Sterility; potential exposure to non-sterile lubricant during the filling process
Distribution
Nationwide
Lot / Code Info
a) Lot D4E20A, exp 3/2016 and b) Lot D4C21A, exp 3/2016
More recalls by Nephron Pharmaceuticals Corp.
Sodium Chloride Inhalation Solution, USP 3%, 60 x 4 mL Sterile Unit-Dose Vials per carton, Rx Only,...
Jun 27, 2016
Sodium Chloride Inhalation Solution, USP 7%, 60 x 4 mL Sterile Unit-Dose Vials, Rx Only, NDC 0487-90...
Jun 27, 2016
Asthmanefrin Racepinephrine Inhalation Solution Bronchodilator, Starter Kit (Racepinephrine 11.25 mg...
Dec 9, 2015 · 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