FDA Drug Recalls

170 recalls · Class III, newest first

Nov 1, 2016 Class III · Low risk

Qnasl (beclomethasone dipropionate)

Failed Content Uniformity: Product was out of specification for spray content uniformity obtained during stability testing.

Terminated Wrong potency / content Teva Pharmaceuticals USA NDC 59310-210-13 D-0171-2017

Nov 1, 2016 Class III · Low risk

Qnasl (beclomethasone dipropionate)

Failed Content Uniformity: Product was out of specification for spray content uniformity obtained during stability testing.

Terminated Wrong potency / content Teva Pharmaceuticals USA NDC 59310-206-06 D-0170-2017

Oct 28, 2016 Class III · Low risk

KENALOG (Triamcinolone Acetonide)

Failed Stability Specifications: Low Out of Specification results for alcohol content.

Terminated Stability / shelf life Sun Pharmaceutical Industries, Inc. D-0148-2017

Oct 27, 2016 Class III · Low risk

Bupropion Hydrochloride Extended-Release Tablets

Failed Dissolution Specifications: The firm was notified that there was a dissolution out of specification result on the 6 month stability samples.

Terminated Dissolution failure Amerisource Health Services NDC 68001-264-05 D-0137-2017

Oct 20, 2016 Class III · Low risk

FIRST Omeprazole 2mg/mL in FIRST PPI Suspension Compounding Kit

Labeling: Label error on declared strength. Package Insert -Error in the Description section of the package insert refers to the strength as 3mg per mL; however it should state 2mg per mL

Terminated Labeling / mix-up CutisPharma, Inc. NDC 65628-070-03 D-0139-2017

Oct 20, 2016 Class III · Low risk

FIRST Omeprazole 2mg/mL in FIRST PPI Suspension Compounding Kit

Labeling: Label error on declared strength. Package Insert -Error in the Description section of the package insert refers to the strength as 3mg per mL; however it should state 2mg per mL

Terminated Labeling / mix-up CutisPharma, Inc. NDC 65628-070-05 D-0138-2017

Oct 19, 2016 Class III · Low risk

Ceftriaxone for Injection

Labeling: Missing Label

Terminated Labeling / mix-up Sandoz Inc NDC 0409-7332-01 D-0145-2017

Oct 19, 2016 Class III · Low risk

Invokamet (canagliflozin and metformin HCl)

Labeling: Incorrect or Missing Package Insert - Xarelto prescribing information outserts may be affixed to the exterior of Invokamet bottles in place of the Invokamet prescribing information outsert.

Terminated Labeling / mix-up Janssen Ortho L.L.C. NDC 50458-543-60 D-0115-2017

Oct 18, 2016 Class III · Low risk

HCG (Chorionic Gonadotropin Lyopholized)

Subpotent Drug: due to failed potency results of 74% (spec. 80-125%).

Terminated Wrong potency / content Town and Country Compounding and Consultation Services, LLC D-0436-2017

Oct 18, 2016 Class III · Low risk

Labeling Not Elsewhere Classified: front labels have the incorrect NDC or 0145-1506-01 instead of the correct NDC of 0145-1506-05 and some back labels have the incorrect indication stating "use for the cure of most jock itch" rather than "use for the cure of most athlete's foot".

Terminated Labeling / mix-up GSK Consumer Healthcare NDC 0145-1506-01 D-0142-2017

Oct 13, 2016 Class III · Low risk

Olanzapine tablets

Failed impurities/degradation specifications: due to out-of-specification result for the Related Substance Compound C (Impurity 6 - N-Oxide at the 18 month stability station.

Terminated Impurity / degradation Dr. Reddy's Laboratories, Inc. NDC 55111-163-30 D-0468-2017

Oct 13, 2016 Class III · Low risk

AHP NIFEdipine Capsules

Presence of Foreign Tablets/Capsules

Terminated Particulate / foreign matter Amerisource Health Services D-0144-2017

Oct 12, 2016 Class III · Low risk

HCG-Vitamin B12 5000 IU-8 mg in 10 mL vial

Labeling; Error on Declared Strength; product description incorrectly states HCG 7500 units instead of 5000 units. The primary panel is correct

Terminated Labeling / mix-up Pharm D Solutions, LLC D-0427-2017

Oct 12, 2016 Class III · Low risk

Testosterone Cypionate 200 mg/mL in Sesame Oil

Incorrect/Undeclared Excipient; product description section of testosterone cypionate incorrectly states "in grapeseed oil" instead of "in sesame oil" . The primary panel is correct

Terminated Chemical / undeclared Pharm D Solutions, LLC D-0426-2017

Oct 6, 2016 Class III · Low risk

NIFEdipine Capsules USP

Presence of Foreign Tablets/Capsules

Terminated Particulate / foreign matter Actavis Elizabeth LLC NDC 0228-2407-10 D-0143-2017

Sep 30, 2016 Class III · Low risk

Paricalcitol Capsules

Failed Impurities/Degradation Specifications: This repackaged product was recalled by its manufacturer due to failed results for impurities.

Terminated Impurity / degradation Amerisource Health Services NDC 60687-106-25 D-0009-2017

Sep 28, 2016 Class III · Low risk

Clonazepam Tablets

Failed Impurities/Degradation Specifications: out of specification result for Clonazepam Related Compound (RC) A (a known impurity) at 16 month timepoint.

Terminated Impurity / degradation Mylan Institutional, Inc. (d.b.a. UDL Laboratories) NDC 51079-882-20 D-0136-2017

Sep 28, 2016 Class III · Low risk

Clonazepam Tablets

Failed Impurities/Degradation Specifications: out of specification result for Clonazepam Related Compound (RC) A (a known impurity) at 15 month timepoint.

Terminated Impurity / degradation Mylan Institutional, Inc. (d.b.a. UDL Laboratories) NDC 51079-881-20 D-0135-2017

Sep 27, 2016 Class III · Low risk