US Drug Recall Register

FDA Drug Recalls

14,801 recalls, newest first

Class I · High risk Terminated

Vancomycin HCl 1.5 gram added to 5% Dextrose 500 mL Total…

Reason Presence of particulate matter - this recall is due to a recent Hospira recall of vancomyicn hydrochloride 10gm vials due to presence of particulate matter.

SCA Pharmaceuticals NDC 70004-0925-44 D-0643-2017
Class II · Moderate risk Terminated

GlipiZIDE Extended-release tablets

Reason Failed dissolution specifications: Glipizide 2.5 mg ER Tablets exceeded dissolution specification rates for the 10 hour testing point.

Amerisource Health Services NDC 68084-295-21 D-0520-2017
Class II · Moderate risk Terminated

CycloSPORINE Capsules

Reason Failed Impurities/Degradations Specifications; out of specification results for Maximum Unknown Impurities and Total Impurities.

Apotex Inc. NDC 60505-0134-0 D-0475-2017
Class III · Low risk Terminated

Q Care Continue Care Kit for the non-ventilated patient

Reason Labeling: Incorrect or Missing Lot and/or Exp Date: The expiration date of the Q Care Continue Care kit is printed with an expiration date of November 13, 2017; rather than the correct date of August 28, 2017 (date of expiration of the Corinz Antiseptic Cleansing & Moisturizing Oral Rinse). Note, the correct expiration date of August 28, 2017, is printed on the Corinz Oral Rinse package.

Sage Products Inc D-0489-2017
Class II · Moderate risk Terminated

Transderm Scop

Reason Labeling: Incorrect Instructions:outer carton contains the incorrect instructions for Step 2 stating "Do cut the patch" rather than the correct instructions of "Do not cut the patch". The pouch containing the patch is labeled correctly.

Sandoz Inc NDC 66758-208-58 D-0481-2017
Class II · Moderate risk Terminated

Mimvey Lo

Reason Failed Impurities/Degradation Specifications: out of specification test results for the norethindrone impurity.

Teva Pharmaceuticals USA NDC 0093-5454-18 D-0479-2017
Class III · Low risk Terminated

Norethindrone Acetate and Ethinyl Estradiol Tablets

Reason Chemical Contamination: out of specification results for impurities were found to be the result of contamination of product from vapors associated with paint thinner used in repair of the manufacturing room.

Mylan Pharmaceuticals Inc. NDC 0378-7280-85 D-0861-2017
Class III · Low risk Terminated

Tarina Fe 1/20

Reason Chemical Contamination: out of specification results for impurities were found to be the result of contamination of product from vapors associated with paint thinner used in repair of the manufacturing room.

Mylan Pharmaceuticals Inc. NDC 50102-128-01 D-0860-2017
Class II · Moderate risk Terminated

Glipizide extended-release tablets

Reason Failed Dissolution Specifications. Above out of specification for dissolution rate observed at the 10 hour testing point.

Actavis Inc NDC 0591-0900-30 D-0476-2017
Class III · Low risk Terminated

Buffered Lidocaine

Reason Labeling; Label Mixup; outer packaging is incorrectly labeled as Buffered Lidocaine 1% instead of correctly as Buffered Lidocaine 0.9%

Pharmedium Services, LLC D-0603-2017
Class II · Moderate risk Terminated

Mirtazapine Tablets

Reason Presence of Foreign Tablets/Capsules; possibility of Glipizide 10 mg tablets commingled

Mylan Institutional, Inc. (d.b.a. UDL Laboratories) NDC 51079-088-20 D-0493-2017
Class II · Moderate risk Terminated

MakeSense PHARMA

Reason CGMP Deviations

Cherry Hill Sales Co. NDC 69020-205-28 D-0483-2017
Class I · High risk Terminated

Vancomycin Hydrochloride for Injection

Reason Presence of Particulate Matter: A hair was found stuck to the stopper of inside a single vial. The hair came in contact with the reconstituted drug product.

Hospira Inc., A Pfizer Company NDC 0409-6510-01 D-0638-2017
Class II · Moderate risk Terminated

Calcipotriene Cream 0.0005%

Reason Incorrect/Undeclared excipients: inadvertent omission of a drug excipient from the the Authorized Generic label and also a warning regarding contact dermatitis from the brand product labeling not being incorporated into the Authorized Generic labeling.

Leo Pharma INC NDC 66993-877-61 D-0510-2017
Class II · Moderate risk Terminated

Mirtazapine Tablets

Reason Presence of Foreign Tablets/Capsules; possibility of Glipizide 10 mg tablet in bottle

Mylan Pharmaceuticals Inc. D-0492-2017
Class II · Moderate risk Terminated

glipiZIDE Extended-Release Tablets

Reason Presence of Foreign Tablets/Capsules; bottles of Glipizide 5 mg tablets may contain Glipizide 10 mg tablets

Mylan Pharmaceuticals Inc. NDC 0378-0342-10 D-0491-2017
Class II · Moderate risk Terminated

Potassium Chloride Oral Solution

Reason Defective Container: Leakage of unit dose cups that may occur at the seal.

VistaPharm, Inc. NDC 66689-047-01 D-0469-2017