DrugAug 29, 2018
VALSARTAN Camber Pharmaceuticals, Inc recall — FDA D-1114-2018
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class IIFDA: CompletedHetero Labs Limited Unit V
August 2018 recalls — page 4
These records include useful source details for the selected month.
DrugAug 29, 2018
Westminster Pharmaceuticals Levothyroxine and Liothyronine (Thyroid Tablets, USP), 1/2 grain recall — FDA D-1180-2018
Failed Content Uniformity Specifications: Product was manufactured using an adulterated active pharmaceutical ingredient; additionally, lack of process controls and good manufacturing…
Class IFDA: TerminatedWestminster Pharmaceuticals LLC
DrugAug 29, 2018
VALSARTAN Camber Pharmaceuticals, Inc recall — FDA D-1115-2018
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class IIFDA: CompletedHetero Labs Limited Unit V
DrugAug 29, 2018
Westminster Pharmaceuticals Levothyroxine and Liothyronine (Thyroid Tablets, USP), 1/4 grain recall — FDA D-1181-2018
Failed Content Uniformity Specifications: Product was manufactured using an adulterated active pharmaceutical ingredient; additionally, lack of process controls and good manufacturing…
Class IFDA: TerminatedWestminster Pharmaceuticals LLC
DrugAug 29, 2018
VALSARTAN Camber Pharmaceuticals, Inc recall — FDA D-1113-2018
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class IIFDA: CompletedHetero Labs Limited Unit V
DrugAug 29, 2018
Jubilant Cadista Pharmaceuticals Valsartan Tablets USP, 160 mg, 90-count bottle recall — FDA D-1105-2018
Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing.
Class IIIFDA: TerminatedJubilant Cadista Pharmaceuticals, Inc.
DrugAug 29, 2018
Preferred Pharmaceuticals Valsartan Tablets USP 320 mg, 90-count, plastic child resistant recall — FDA D-1107-2018
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class IIFDA: TerminatedPreferred Pharmaceuticals, Inc.
DrugAug 29, 2018
Jubilant Cadista Pharmaceuticals Valsartan Tablets USP, 80 mg, 90-count bottle recall — FDA D-1104-2018
Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing.
Class IIIFDA: TerminatedJubilant Cadista Pharmaceuticals, Inc.
DrugAug 29, 2018
A-S Medication Solutions LLC Valsartan and Hydrochlorothiazide Tablets, Valsartan 160 MG and recall — FDA D-1110-2018
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class IIFDA: OngoingA-S Medication Solutions LLC.
DrugAug 29, 2018
VALSARTAN Camber Pharmaceuticals, Inc recall — FDA D-1116-2018
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class IIFDA: CompletedHetero Labs Limited Unit V
DrugAug 29, 2018
Jubilant Cadista Pharmaceuticals Valsartan Tablets USP, 40 mg, 30-count bottle recall — FDA D-1103-2018
Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing.
Class IIIFDA: TerminatedJubilant Cadista Pharmaceuticals, Inc.
DrugAug 29, 2018
Mylan Institutional Diltiazem HCl Extended-release Capsules, USP 120 mg, 80 capsules, 8 recall — FDA D-1112-2018
Failed Impurities/Degradation Specifications; out of specification results for related compound per the manufacturer
Class IIIFDA: TerminatedMylan Institutional, Inc. (d.b.a. UDL Laboratories)
DrugAug 29, 2018
A-S Medication Solutions LLC Valsartan and Hydrochlorothiazide Tablets, Valsartan 320 MG and recall — FDA D-1111-2018
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class IIFDA: OngoingA-S Medication Solutions LLC.
DrugAug 29, 2018
Westminster Pharmaceuticals Levothyroxine and Liothyronine (Thyroid Tablets, USP), 1 & 1/2 recall — FDA D-1179-2018
Failed Content Uniformity Specifications: Product was manufactured using an adulterated active pharmaceutical ingredient; additionally, lack of process controls and good manufacturing…
Class IFDA: TerminatedWestminster Pharmaceuticals LLC
DrugAug 29, 2018
Westminster Pharmaceuticals Levothyroxine and Liothyronine (Thyroid Tablets, USP), 2 grain recall — FDA D-1182-2018
Failed Content Uniformity Specifications: Product was manufactured using an adulterated active pharmaceutical ingredient; additionally, lack of process controls and good manufacturing…
Class IFDA: TerminatedWestminster Pharmaceuticals LLC
DrugAug 29, 2018
Jubilant Cadista Pharmaceuticals Valsartan Tablets USP, 320 mg, 90-count bottle recall — FDA D-1106-2018
Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing.
Class IIIFDA: TerminatedJubilant Cadista Pharmaceuticals, Inc.
DrugAug 29, 2018
Westminster Pharmaceuticals Levothyroxine and Liothyronine (Thyroid Tablets, USP), 1 grain recall — FDA D-1178-2018
Failed Content Uniformity Specifications: Product was manufactured using an adulterated active pharmaceutical ingredient; additionally, lack of process controls and good manufacturing…
Class IFDA: TerminatedWestminster Pharmaceuticals LLC
VehicleAug 23, 2018
Chrysler axle recall — NHTSA campaign 18V556000
Chrysler (FCA US LLC) is recalling certain 2018-2019 RAM 1500 trucks. The rear differential may have been insufficiently filled, possibly resulting in its failure.
axleChrysler (FCA US LLC)
Medical DeviceAug 22, 2018
Megadyne Medical Products MegaPower Electrosurgical Generator, Product code 1000, GTIN recall — FDA Z-2792-2018
If two devices are plugged into the same channel/port in the generator, both devices activate. If one device is left laying on the patient, the result could be burning of the patient.
Class IIFDA: TerminatedMegadyne Medical Products, Inc.
Medical DeviceAug 22, 2018
ICU Medical de Mexico, S.A. de C.V 6" Smallbore Ext Set w/6-Port NanoClave Manifold, Check recall — FDA Z-2816-2018
ICU Medical is expanding the scope of their previously initiated recall to include additional I.V. Administration Sets with NanoClave manifold due to the potential to develop a leak or for…
Class IIFDA: TerminatedICU Medical de Mexico, S.A. de C.V.
Medical DeviceAug 22, 2018
Mako Surgical Rio System Irrigation Clip - Catalog # 111690 Product Usage: The RESTORIS recall — FDA Z-2794-2018
Out of tolerance.
Class IIFDA: TerminatedMako Surgical Corporation
Medical DeviceAug 22, 2018
ICU Medical de Mexico, S.A. de C.V 28 cm (11") PUR Bifuse Ext Set w/6-Port NanoClave recall — FDA Z-2804-2018
ICU Medical is expanding the scope of their previously initiated recall to include additional I.V. Administration Sets with NanoClave manifold due to the potential to develop a leak or for…
Class IIFDA: TerminatedICU Medical de Mexico, S.A. de C.V.
Medical DeviceAug 22, 2018
NxStage Express Fluid Warmer recall — FDA Z-2793-2018
There is a potential risk of electrical fire when fluid leaks into the power receptacle on the back of the warmer. The risk exists any time the warmer is plugged in. The firm has received 7…
Class IIFDA: TerminatedNxStage Medical, Inc.
Medical DeviceAug 22, 2018
Cook VentriClear Ventricular Drainage Catheter Set, Cat recall — FDA Z-2791-2018
This lot of VentriClear failed endotoxin testing. Potential adverse events include immune responses ranging from non-specific febrile reaction to life-threatening systemic inflammatory…
Class IIFDA: TerminatedCook Inc.
How to use this monthly recall archive
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.