US Drug Recall Register

FDA Drug Recalls

1,709 recalls · Class III, newest first

Class III · Low risk Terminated

Mercaptopurine Tablets USP

Reason Labeling: Incorrect or Missing Lot and/or Exp Date: This recall is being conducted because the product was given 36 month expiration dates instead of the filed 24 months.

Boehringer Ingelheim Roxane Inc NDC 0054-4581-11 D-1314-2014
Class III · Low risk Terminated

Azathioprine Tablets USP

Reason Labeling: Incorrect or Missing Lot and/or Exp Date: This recall is being conducted because the product was given 36 month expiration dates instead of the filed 24 months.

Boehringer Ingelheim Roxane Inc NDC 0054-4084-25 D-1313-2014
Class III · Low risk Terminated

Psyllium Fiber

Reason Labeling: Label Error on Declared Strength; Listed active ingredient strength is inaccurate.

Konsyl Pharmaceuticals Inc D-1315-2014
Class III · Low risk Terminated

Glytone Acne

Reason Failed Stability Specifications: Out of specification results for viscosity in one lot of Glytone Acne Treatment Facial Cleanser.

Genesis Pharmaceutical, Inc. D-1285-2014
Class III · Low risk Terminated

Spiriva HandiHaler

Reason Defective Delivery System: Potential for dose delivery out of specification due to interation of the drug product powder with the lubricant on the interior of the capsule shell.

Boehringer Ingelheim Roxane Inc NDC 0597-0075-75 D-1230-2014
Class III · Low risk Terminated

Demerol

Reason Labeling; Missing label; ampoules are missing the immediate container label

Hospira Inc. NDC 0409-1203-01 D-1226-2014
Class III · Low risk Terminated

Risperidone Oral Solution

Reason Failed Impurities/Degradation Specifications: Out of Specification for an impurity at the 18 month stability time point.

Apotex Inc. NDC 60505-0380-1 D-1299-2014
Class III · Low risk Terminated

Polidocanol 1% Solution

Reason Labeling: Incorrect Expiration Date; Expiration date is earlier than listed on vial.

John W Hollis Inc D-1259-2014
Class III · Low risk Terminated

Papaverine 60 mg

Reason Labeling: Incorrect Expiration Date; Expiration date is earlier than listed on vial.

John W Hollis Inc D-1258-2014
Class III · Low risk Terminated

Ritalin HCl

Reason Labeling: Incorrect or Missing Package Insert; The back of the Medication Guide attached to the Package Insert for Ritalin Tablets was printed with information related to Ritalin SR (Sustained Release) Tablets. Both products, Ritalin Tablets and Ritalin SR Tablets utilize a combined Package Insert. The individual Medication Guides are attached to the Package Insert via a perforation. Although t

Novartis Pharmaceuticals Corp. NDC 0078-0441-05 D-1228-2014
Class III · Low risk Terminated

Ritalin HCl

Reason Labeling: Incorrect or Missing Package Insert; The back of the Medication Guide attached to the Package Insert for Ritalin Tablets was printed with information related to Ritalin SR (Sustained Release) Tablets. Both products, Ritalin Tablets and Ritalin SR Tablets utilize a combined Package Insert. The individual Medication Guides are attached to the Package Insert via a perforation. Although t

Novartis Pharmaceuticals Corp. NDC 0078-0440-05 D-1227-2014
Class III · Low risk Terminated

Venlafaxine Hydrochloride

Reason Failed Dissolution Specification: Out of Specification dissolution results at 12 month interval.

McKesson Packaging Services NDC 63739-0512-10 D-1167-2014
Class III · Low risk Terminated

Advil PM Caplets

Reason Subpotent Drug: This lot is being recalled because of out-of-specification test results for Diphenhydramine citrate.

Pfizer Us Pharmaceutical Group NDC 0573-0164-43 D-1166-2014
Class III · Low risk Terminated

Nicorette Lozenge and NicoDerm CQ

Reason Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.

GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline D-1247-2014
Class III · Low risk Terminated

Nicorette

Reason Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.

GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline D-1246-2014
Class III · Low risk Terminated

Nicorette

Reason Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.

GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline D-1245-2014
Class III · Low risk Terminated

Nicorette Lozenge

Reason Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.

GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline D-1244-2014
Class III · Low risk Terminated

Nicotine polacrilex lozenge

Reason Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.

GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline D-1243-2014
Class III · Low risk Terminated

Nicotine polacrilex lozenge

Reason Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.

GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline D-1242-2014
Class III · Low risk Terminated

Nicotine polacrilex lozenge

Reason Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.

GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline D-1241-2014
Class III · Low risk Terminated

Nicotine polacrilex lozenge

Reason Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.

GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline D-1240-2014
Class III · Low risk Terminated

Nicotine polacrilex lozenge

Reason Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.

GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline D-1239-2014
Class III · Low risk Terminated

Nicotine polacrilex lozenge

Reason Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.

GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline D-1238-2014
Class III · Low risk Terminated

Atripla

Reason Presence of Foreign Substance: Red Silicone Rubber Particulates are Present in Drug.

Gilead Sciences, Inc. NDC 15584-0101-1 D-1090-2014
Class III · Low risk Terminated

Qvar¿

Reason Failed Impurity/Degradation Specification; for 17-BMP at the 9 and 18 month stability time point

Teva Pharmaceuticals USA D-1190-2014