Lack of Assurance of Sterility
Drugs Recalls
Prescription and over-the-counter medications
CGMP Deviations: Confirmed customer compliant of odor when turning on a cylinder of medical air.
Atropine 0.01% Ophth Solution, 15mL bottle, Rx only, Walter's Pharmacy 401 N 17th St Allentown, PA 610-435-4706, NDC 99999-9019-09
Walter's Pharmacy
Lack of Assurance of Sterility
Labeling: Label Error on Declared Strength: Label incorrectly identifies product dose as 5ml instead of 10 ml.
CGMP Deviations: Confirmed customer compliant of odor when turning on a cylinder of medical air.
Tobramycin 15mg/mL Ophth Solution, packaged in 5mL and 10mL bottles, Rx only, Walter's Pharmacy 401 N 17th St., Allentown, PA 610-435-4706, NDC 99999-9996-35
Walter's Pharmacy
Lack of Assurance of Sterility
Edetate Disodium 2% Ophth Solution, 15mL bottle, Rx only, Walter's Pharmacy, 401 N 17th St, Allentown, PA 610-435-4706, NDC 99999-9019-47
Walter's Pharmacy
Lack of Assurance of Sterility
Cefazolin 50 mg/mL Ophth Solution, 10mL bottle, Rx only, Walter's Pharmacy, 401 N 17th St, Allentown, PA 610-435-4706, NDC 99999-9999-69 / 89999-9001-04
Walter's Pharmacy
Lack of Assurance of Sterility
Lidocaine Nebulizer 1% Solution, Rx only, Walter's Pharmacy, 401 N 17th St, Allentown, PA 610-435-4706, NDC 99999-9020-61
Walter's Pharmacy
Lack of Assurance of Sterility
Labeling: Incorrect or Missing Lot and/or Exp Date
Vancomycin 50mg/mL Solution, 10mL bottle, Rx only, Walter's Pharmacy, 401 N 17th St, Allentown, PA 610-435-4706, NDC 99999-9991-54
Walter's Pharmacy
Lack of Assurance of Sterility
Tobramycin 14 mg/mL Ophth Solution, 10mL bottle, Rx only, Walter's Pharmacy, 401 N 17th St, Allentown, PA 610-435-4706, NDC 99999-9996-60
Walter's Pharmacy
Lack of Assurance of Sterility
Rose Bengal 1% Ophth Solution, 5mL bottle, Rx only, Walter's Pharmacy 401 N 17th St., Allentown, PA 610-435-4706
Walter's Pharmacy
Lack of Assurance of Sterility
Labeling: Label Mix-Up
Silver Nitrate 1% Ophth Solution, 5mL bottle, Rx only, Walter's Pharmacy 401 N 17th St., Allentown, PA 610-435-4706, NDC 99999-9991-92
Walter's Pharmacy
Lack of Assurance of Sterility
Acetylcysteine 10% Ophth Solution, 10mL bottle, Rx only, Walter's Pharmacy 401 N 17th St, Allentown, PA 610-435-4706, NDC 99999-9018-33
Walter's Pharmacy
Lack of Assurance of Sterility
Defective Delivery System: Some units have actuation counters set to a number other than 60.
cGMP Deviations; trailer may not have met GMP requirements prior to filling
Fluconazole Injection, USP (in 0.9% Sodium Chloride), 200 mg per 100 ml, Single-Dose Container Bag, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195, NDC 25021-0113-82
Sagent Pharmaceuticals
Cross contamination with other products: metronidazole
NABUMETONE Tablets USP, 750 mg, 100 count bottle,Teva Pharmaceutical Industries Ltd., Jerusalem, 91010, ISRAEL
Teva Pharmaceuticals USA
Labeling: Not Elsewhere Classified: Lack of leaflets and approved labels on bottles.