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FDA Recalls
›Drug Recalls

FDA Drug Recalls

Recalls of prescription drugs, over-the-counter medications, and compounded pharmaceuticals.

Classification

All Class I Class II Class III

Status

All Ongoing Completed Terminated

Date

All time Past 30 days Past 12 months

Showing 11961–11980 of 17,816 recalls

Class IITerminated

Paliperidone Extended-release Tablets, 1.5 mg, 30 count bottles, Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV --- NDC 0378-3978-93

Mylan Pharmaceuticals Inc.

Failed Dissolution Specifications; three month stability time point.

February 12, 2016 · DrugView details →

Class IITerminated

Vancomycin 25mg/mL Solution, 10 mL bottles, Rx only, Walter's Pharmacy 401 N 17th St., Allentown, PA 610-435-4706, NDC 99999-9003-78

Walter's Pharmacy

Lack of Assurance of Sterility

February 12, 2016 · DrugView details →

Class IITerminated

Edetate Disodium 3% Ophth Solution, 10mL 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

February 12, 2016 · DrugView details →

Class IITerminated

Lidocaine Nebulizer 2% Solution, packaged in 50mL, 100mL, 120mL, and 150mL bottles, Rx only, Walter's Pharmacy, 401 N 17th St, Allentown, PA 610-435-4706, NDC 99999-9000-99

Walter's Pharmacy

Lack of Assurance of Sterility

February 12, 2016 · DrugView details →

Class IITerminated

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

February 12, 2016 · DrugView details →

Class IITerminated

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

February 12, 2016 · DrugView details →

Class IITerminated

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

February 12, 2016 · DrugView details →

Class IIITerminated

Minocycline Hydrochloride Capsules USP, 100 mg*, 30 Capsules (3 x 10) Unit Dose blisters (NDC 50268-569-11, barcode 5026856911) per carton (NDC 50268-569-13, barcode 5026856913), Rx only, Manufactured for: AvKARE, Inc., Pulaski, TN 38478.

Apace KY LLC

Labeling: Incorrect or Missing Lot and/or Exp Date: the individual blisters are mislabeled with an incorrect lot number of 13560 rather than the correct lot number of 13650.

February 12, 2016 · DrugView details →

Class IITerminated

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

February 12, 2016 · DrugView details →

Class IITerminated

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

February 12, 2016 · DrugView details →

Class IITerminated

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

February 12, 2016 · DrugView details →

Class IITerminated

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

February 12, 2016 · DrugView details →

Class IITerminated

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

February 12, 2016 · DrugView details →

Class IIITerminated

Scrub-Stat 4 (chlorhexidine gluconate) Foam Forming Solution, 4%, packaged in a) 800 mL Plastic (HDPE) Bottles (NDC 47593-265-36), b) 1250 mL Plastic (HDPE) Bottles (NDC 47593-468-59), OTC, Ecolab, St Paul, MN 55102

Ecolab Inc

Subpotent drug

February 12, 2016 · DrugView details →

Class IITerminated

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

February 12, 2016 · DrugView details →

Class IITerminated

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

February 12, 2016 · DrugView details →

Class IITerminated

Alendronate Sodium Tablets, USP, 70 mg*, 4-count blisters per carton, Rx only, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India; Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512; NDC 41616-638-68, UPC 3 41616 63868 4.

Sun Pharma Global Fze

Failed Impurities/Degradation Specifications: Observed levels of highest unknown impurity exceeding specification limit at the 3 month stability time point.

February 11, 2016 · DrugView details →

Class IIITerminated

sulfur8 medicated LIGHT FORMULA (sulfur) anti-dandruff hair & scalp conditioner, 2%, packaged in a) 2 OZ (57g) jar (UPC 0 75610 43510 8), and b) 4 OZ (113g) jar (UPC 0 75610 43610 5), 1 dozen jars per case, J. Strickland & Co., PO Box 1637, Olive Branch, MS 38654

J. Strickland and Co

Subpotent Drug: failed at the 3 and 6 month stability time points.

February 11, 2016 · DrugView details →

Class ITerminated

Morphine Sulfate 0.5 mg/mL, Preservative Free in 0.9% Sodium Chloride, Rx, total volume 1 mL, This is a compounded drug, CII, IV Use, syringe, Pharmakon Pharmaceuticals, NDC 45183-0322-78.

Pharmakon Pharmaceuticals

Super-Potent Drug: Out of specification for potency results (high) were obtained for one lot of morphine sulfate Inj.

February 11, 2016 · DrugView details →

Class IIITerminated

Adult Robitussin PEAK COLD Cough & Chest Congestion DM Liquid 8 oz. Bottle (237 mL), Distributed by Pfizer, Madison, NJ 07940, NDC 0031-8736-18

Pfizer Inc

Labeling: Label Mix-Up

February 10, 2016 · DrugView details →

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