Mental Health Medication Recalls

Recalls of antidepressants, anti-anxiety and related psychiatric medications.

226 recalls in this category, newest first.

Class III · Low risk Terminated Oct 27, 2016

Bupropion Hydrochloride Extended-Release Tablets, USP (XL), 300 mg, a) 90-count bottle (NDC 68001-264-05), b) 500-count bottle…

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

Amerisource Health Services NDC 68001-264-05 D-0137-2017

Class II · Moderate risk Terminated Oct 19, 2016

Duloxetine Delayed-release Capsules USP 30 mg 30-count bottles, Rx Only, Manufactured by: Inventia Healthcare Private Limited…

Reason Failed Tablet/Capsule Specifications: Capsule shell (s) opening inside the bottle The Initial reports stated one or two capsules in a bottle count…

Inventia Healthcare Private Limited NDC 69097-298-02 D-0224-2017

Class III · Low risk Terminated Sep 28, 2016

Clonazepam Tablets, USP, 1.0 mg, packaged in a 100- count unit dose box of 10 x 10 blister cards, Rx only, Manufactured by Mylan…

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

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

Class III · Low risk Terminated Sep 28, 2016

Clonazepam Tablets, USP, 0.5 mg, packaged in a)100- count unit dose box of 10 x 10 blister cards (NDC 51079-881-20) and b)…

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

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

Class III · Low risk Terminated Sep 15, 2016

Xanax (Alprazolam) USP, CIV, 0.5 mg tablets , 10 x 10 blister cards per carton, Rx Only, Manufactured by Sandoz Inc., Princeton…

Reason Labeling: Missing Label-Primary packaging label (i.e. blister card) is blank and contains no product information (e.g. product name, strength, lot…

Mckesson Packaging Services NDC 63739-669-10 D-1527-2016

Class III · Low risk Terminated Sep 13, 2016

buPROPion Hydrochloride Extended-release Tablets, USP (SR), 150 mg, Twice-A-Day, in 60 count bottles, Rx only, Distributed by…

Reason Failed Dissolution Specifications

Sun Pharmaceutical Industries, Inc. NDC 47335-737-86 D-0007-2017

Class III · Low risk Terminated Aug 4, 2016

buPROPion Hydrochloride Extended-Release Tablets, USP (XL), 300mg, 500-count bottle, Rx only, Manufactured by: Cadila Healthcare…

Reason Failed dissolution specifications - the out of specification result for dissolution was identified during 3 month stability testing.

Amerisource Health Services NDC 68001-264-03 D-1501-2016

Class II · Moderate risk Terminated Aug 3, 2016

Venlafaxine Hydrochloride Extended-Release Capsules, 75 mg, 90 capsules per bottle, Rx Only, GSMS, NDC # 60429-122-90

Reason Failed Dissolution Specifications: Out-of-specification results in retained sample.

Golden State Medical Supply Inc. NDC 60429-122-90 D-1459-2016

Class II · Moderate risk Terminated Aug 3, 2016

Venlafaxine Hydrochloride Extended-Release Capsules, 150 mg, a) 30 capsules per bottle, NDC # 60429-123-30, b) 90 capsules per…

Reason Failed Dissolution Specifications: Out-of-specification results in retained sample.

Golden State Medical Supply Inc. NDC 60429-123-30 D-1458-2016

Class III · Low risk Terminated Aug 3, 2016

BuPROPion Hydrochloride Extended-Release Tablets, USP (XL) 300 mg, Rx Only, 500-count bottles, Manufactured by Cadila…

Reason Failed Dissolution Specifications: Product did not meet dissolution specification at an intermediate time point.

Zydus Pharmaceuticals USA Inc NDC 68382-354-05 D-0149-2017

Class II · Moderate risk Terminated Jul 19, 2016

Venlafaxine HCL ER Capsule USP, 75mg, packaged in a) 30-count bottles (NDC 68382-035-06), b) 90-count bottles (NDC 68382-035-16)…

Reason Failed Dissolution Specifications: out of specification dissolution results in retained samples

Zydus Pharmaceuticals USA Inc NDC 68382-035-06 D-1461-2016

Class II · Moderate risk Terminated Jul 19, 2016

Venlafaxine HCL ER Capsule USP, 150mg, packaged in a) 30-count bottles (NDC 68382-036-06), b) 90-count bottles (NDC…

Reason Failed Dissolution Specifications: out of specification dissolution results in retained samples

Zydus Pharmaceuticals USA Inc NDC 68382-036-06 D-1460-2016

Class III · Low risk Terminated Jun 28, 2016

DULOXETINE Delayed-Release Capsules, USP, 60 mg, 1000 count bottles, Rx only, Manufactured by: Laboratorios del Dr. Esteve, SA…

Reason Labeling; Incorrect or Missing Lot and/or Exp Date; incorrect expiration date on container label is 02/2019, correct expiration date should be 02/2018

Golden State Medical Supply Inc. NDC 60429-166-10 D-1255-2016

Class III · Low risk Terminated Jun 27, 2016

buPROPion Hydrochloride Extended Release Tablets USP (SR) 150 mg Rx Only 60 tablets Distributed by Sun Pharmaceutical Industries…

Reason Failed Dissolution Specifications

Sun Pharmaceutical Industries, Inc. NDC 47335-737-86 D-1446-2016

Class II · Moderate risk Terminated Jun 22, 2016

Alprazolam Extended-release Tablets, USP, 1 mg, 60-count bottle, Rx Only, Manufactured and Distributed by: Mylan Pharmaceuticals…

Reason Failed Dissolution Specifications

Mylan Pharmaceuticals Inc. NDC 0378-5022-91 D-0706-2017

Class II · Moderate risk Terminated Apr 28, 2016

Zoloft (sertraline HCl) tablets, 100 mg*, 30 count bottles, Rx only, Distributed by Roerig, Division of Pfizer, Inc., NY NY…

Reason Failed Tablet/Capsule Specifications: thick tablets exceeding specifications were found.

Pfizer Inc. NDC 0049-4910-30 D-0857-2016

Class III · Low risk Terminated Apr 8, 2016

BuPROPion Hydrochloride Extended-release Tablets, USP (SR), 200 mg, packaged in a) 60-count bottles (NDC 59746-317-60) and b)…

Reason Failed Impurities/Degradation Specifications: high out of specification results for one of the known degradation products, m-chlorobenzoic acid.

Jubilant Cadista Pharmaceuticals, Inc. NDC 59746-317-60 D-0671-2017

Class III · Low risk Terminated Apr 8, 2016

BuPROPion Hydrochloride Extended-release Tablets, USP (SR), 150 mg, packaged in a) 60-count bottles (NDC 59746-316-60) and b)…

Reason Failed Impurities/Degradation Specifications: high out of specification results for one of the known degradation products, m-chlorobenzoic acid.

Jubilant Cadista Pharmaceuticals, Inc. NDC 59746-316-60 D-0670-2017

Class III · Low risk Terminated Apr 8, 2016

BuPROPion Hydrochloride Extended-release Tablets, USP (SR), 100 mg, packaged in a) 60-count bottles (NDC 59746-315-60) and b)…

Reason Failed Impurities/Degradation Specifications: high out of specification results for one of the known degradation products, m-chlorobenzoic acid.

Jubilant Cadista Pharmaceuticals, Inc. NDC 59746-315-60 D-0669-2017

Class II · Moderate risk Terminated Mar 25, 2016

All citalopram Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA…

Reason Lack of Processing Controls

Reliable Rexall-A Compounding Pharmacy D-1090-2016

Class III · Low risk Terminated Mar 25, 2016

Venlafaxine 75 mg Tablet, Compare to Effexor 75 mg Tablet, a) 30-count bottle (NDC 636290-3324-2), b) 100-count bottle (NDC…

Reason Labeling: Label Mix-Up: Bryant Ranch received Tevas venlafaxine hydrochloride extended-release tablets for repackaging, but labeled it incorrectly as…

Bryant Ranch Prepack Inc. NDC 63629-3324-6 D-0837-2016

Class III · Low risk Terminated Mar 24, 2016