Drug Recalls

17,680 Records

Prescription & OTC drug enforcement reports

6,275 results found for sterility Page 64 of 251
BIOTA Biosciences LLC
Class II Terminated
Sterile Curcumin, 4mg/mL, 10mL vial
Reason: Lack of Assurance of Sterility and Marketed without an approved NDA/ANDA: Product contains unapproved Cannabidiol and Curcumin
D-1327-2020 July 1, 2020 Seattle, WA
BIOTA Biosciences LLC
Class II Terminated
Sterile Curcumin 50mg/mL, 10 mL vial
Reason: Lack of Assurance of Sterility and Marketed without an approved NDA/ANDA: Product contains unapproved Cannabidiol and Curcumin
D-1330-2020 July 1, 2020 Seattle, WA
BIOTA Biosciences LLC
Class II Terminated
Sterile Cannabidiol (CBD) 4mg/mL, 10mL vial
Reason: Lack of Assurance of Sterility and Marketed without an approved NDA/ANDA: Product contains unapproved Cannabidiol and Curcumin
D-1326-2020 July 1, 2020 Seattle, WA
PharMEDium Services, LLC
Class II Terminated
rocuronium Bromide, 10 mg per mL, 50 mg per 5 mL, 5 mL BD Syringe, for IV Use, PharMEDium 13N. Davis Ave. Cleveland MS 36732. NDC 71019-321-05
Reason: Firm is recalling 46 lots of various products because of a lack of sterility assurance.
D-1087-2020 April 15, 2020 Dayton, NJ
PharMEDium Services, LLC
Class II Terminated
ePHEDrine Sulfate, 5 mg per mL, 50 mg per 10 mL, In 0.9% Sodium Chloride 10 mL syringe, For IV Use Preservative Free PharMEDium 913 N. Davis Ave. Cleveland, MS NDC 71030-003-12
Reason: Firm is recalling 46 lots of various products because of a lack of sterility assurance.
D-1081-2020 April 15, 2020 Dayton, NJ
PharMEDium Services, LLC
Class II Terminated
ePHEDrine Sulfate, 5 mg per mL, 25 mg per 5 mL in 0.9% Sodium Chloride, 5 mL syringe, For IV use, Preservative Free, PharMEDium 913 W Davis Ave Cleveland MS 38732 NDC 71030-003-09
Reason: Firm is recalling 46 lots of various products because of a lack of sterility assurance.
D-1088-2020 April 15, 2020 Dayton, NJ
Innovative Intrathecal Solutions, Inc. dba Innovative Compounding Pharmacy
Class II Terminated
Hydroxyprogesterone Caproate (BUD) 350mg/ml , 4 mL, Injectable, Rx only, INNOVATIVE COMPOUNDING PHARMACY, 41536 EASTMAN DRIVE SUITE A MURRIETA , CA 92562 951-304-9530
Reason: Lack of Assurance of Sterility
D-1097-2020 April 15, 2020 Murrieta, CA
Innovative Intrathecal Solutions, Inc. dba Innovative Compounding Pharmacy
Class II Terminated
Alprostadil 10mcg/Papaverine 30mg/Phentolamine 1mg/ml lnj Soln, 5 mL, Injectable, Rx only, INNOVATIVE COMPOUNDING PHARMACY, 41536 EASTMAN DRIVE SUITE A MURRIETA , CA 92562 951-304-9530
Reason: Lack of Assurance of Sterility
D-1099-2020 April 15, 2020 Murrieta, CA
PharMEDium Services, LLC
Class II Terminated
ePHEDrine Sulfate 10 mg per mL 50 mg per 5 mL in 0.9% 5 mL Sodium Chloride 5 mL syringe, For IV Use, Rx Only, PharMEDium 913 N Davis Avenue Cleveland, MS NDC 71030-001-09
Reason: Firm is recalling 46 lots of various products because of a lack of sterility assurance.
D-1091-2020 April 15, 2020 Dayton, NJ
PharMEDium Services, LLC
Class II Terminated
fentaNYL Citrate 10 mcg per mL, 2,500 mcg per 250 mL, 250 mL in a LifeCare Bag, in Sodium Chloride 0.9%. Rx Only, PharMEDium Services, LLC 913 N. Davis Ave Cleveland, MS 36732 NDC 61553-113-50
Reason: Firm is recalling 46 lots of various products because of a lack of sterility assurance.
D-1085-2020 April 15, 2020 Dayton, NJ
PharMEDium Services, LLC
Class II Terminated
succinylcholine Chloride, 20 mg per 5 mL, 100 mg per 5 mL, 5 mL BD Syringe, For IV Use, PharMEDium 913 N. Davis Ave, Cleveland, MS. NDC 71019-341-04
Reason: Firm is recalling 46 lots of various products because of a lack of sterility assurance.
D-1086-2020 April 15, 2020 Dayton, NJ
PharMEDium Services, LLC
Class II Terminated
HYDROmorphone in 0.9% Sodium Chloride HCl, 1 mg per mL, For IV Use, 30 mg per 30 mL, 30 mL in a 35 mL Monoject Barrel Syringe, PharMEDium Services LLC 913 M. Davis Ave Cleveland, MS. NDC 61553-166-44
Reason: Firm is recalling 46 lots of various products because of a lack of sterility assurance.
D-1084-2020 April 15, 2020 Dayton, NJ
PharMEDium Services, LLC
Class II Terminated
nICARdipine HCl (0.1 mg/mL) 1 mg/10mL, in 0.9% Sodium Chloride Injection USP, 10 ml in a 20mL syringe, Rx Only, PharMEDium Services LLC 12620 W. Airport Boulevard #130 Sugar Land, TX 77470. NDC 71019...
Reason: Firm is recalling 46 lots of various products because of a lack of sterility assurance.
D-1082-2020 April 15, 2020 Dayton, NJ
PharMEDium Services, LLC
Class II Terminated
fentaNYL Citrate Injection, 50 mcg per mL, 250 mcg per 5 mL 5 mL syringe, For IV Use, Rx Only, PharMEDium Services, LLC 36 Stutte Road Dayton, NJ. NDC 61553-306-33
Reason: Firm is recalling 46 lots of various products because of a lack of sterility assurance.
D-1092-2020 April 15, 2020 Dayton, NJ
Innovative Intrathecal Solutions, Inc. dba Innovative Compounding Pharmacy
Class II Terminated
MIC-8 (Methionine 15mg /Inositol 50 mg/Choline 100 mg/B-12 6mcg/ml) , 10 mL, Injectable, Rx only, INNOVATIVE COMPOUNDING PHARMACY, 41536 EASTMAN DRIVE SUITE A MURRIETA , CA 92562 951-304-9530
Reason: Lack of Assurance of Sterility
D-1096-2020 April 15, 2020 Murrieta, CA
PharMEDium Services, LLC
Class II Terminated
rocuronium Bromide 10 mg per mL 50 mg per 5 mL, 5 mL BD Syringe, For IV Use, PharMEDium 913 N. Davis Ave. Cleveland, MS. Preservative Free, NDC 71019-321-10
Reason: Firm is recalling 46 lots of various products because of a lack of sterility assurance.
D-1083-2020 April 15, 2020 Dayton, NJ
PharMEDium Services, LLC
Class II Terminated
fentaNYL Citrate Injection 50 mcg per mL, 100 mcg per 2 mL, 2 mL per syringe, For IV Use, Rx Only, PharMEDium Services, LLC 913 N. Davis Ave Cleveland, MS 05810. NDC 61553-303-28
Reason: Firm is recalling 46 lots of various products because of a lack of sterility assurance.
D-1093-2020 April 15, 2020 Dayton, NJ
Innovative Intrathecal Solutions, Inc. dba Innovative Compounding Pharmacy
Class II Terminated
Testosterone Cypionate In Sesame Oil 200mg/ml, 5 mL, Injectable, Rx only, INNOVATIVE COMPOUNDING PHARMACY, 41536 EASTMAN DRIVE SUITE A MURRIETA , CA 92562 951-304-9530
Reason: Lack of Assurance of Sterility
D-1098-2020 April 15, 2020 Murrieta, CA
Innovative Intrathecal Solutions, Inc. dba Innovative Compounding Pharmacy
Class II Terminated
Methylcobalamin Soln. 1000 mcg/ml, 10 mL, Injectable, Rx only, INNOVATIVE COMPOUNDING PHARMACY, 41536 EASTMAN DRIVE SUITE A MURRIETA , CA 92562 951-304-9530
Reason: Lack of Assurance of Sterility
D-1095-2020 April 15, 2020 Murrieta, CA
PharMEDium Services, LLC
Class II Terminated
fentaNYL Citrate 50 mcg per mL, (Preservative Free) Injection, For IV use, 1,500 mcg per 30 mL, 30 mL Total Volume, in a 35 mL Monoject Barrel Syringe, PharMEDium Services, LLC 913 N. Davis Avenue Cl...
Reason: Firm is recalling 46 lots of various products because of a lack of sterility assurance.
D-1089-2020 April 15, 2020 Dayton, NJ
PharMEDium Services, LLC
Class II Terminated
ePHEDrine Sulfate 5 mg per mL 25 mg per 5 mL, in 0.9% Sodium Chloride, 5 mL BD Syringe, For IV Use, Rx Only, PharMEDium 913 N. Davis Ave. Cleveland, MS 98732 NDC 71030-003-02
Reason: Firm is recalling 46 lots of various products because of a lack of sterility assurance.
D-1090-2020 April 15, 2020 Dayton, NJ
Medical Center Pharmacy, Inc.
Class II Terminated
*Morphine 2 mg/mL Cassette, 100 mL CADD Cassette, Rx only, Medical Center Pharmacy, 2401 N. Ocoee Street, Cleveland, TN 37311, NDC 00409-1134-03.
Reason: Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
D-1075-2020 April 8, 2020 Cleveland, TN
Medical Center Pharmacy, Inc.
Class II Terminated
C-*Gentamicin/Bacitracin Bladder Irrigation in N.S., 250 mL bags, Rx only, Medical Center Pharmacy, 2401 Ocoee Street, Cleveland, TN 37311, NDC 63323-0010-02.
Reason: Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
D-1076-2020 April 8, 2020 Cleveland, TN
Medical Center Pharmacy, Inc.
Class II Terminated
*Mitomycin 0.04% Ophth DR eye drops, 5 mL bottle, Rx only, Medical Center Pharmacy, 2401 N. Ocoee Street, Cleveland, TN 37311, NDC 67457-0518-05.
Reason: Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
D-1077-2020 April 8, 2020 Cleveland, TN
Medical Center Pharmacy, Inc.
Class II Terminated
C-*Vancomycin Opthal 14 mg drops, 5 mL bottle, Rx only, Medical Center Pharmacy, 2401 Ocoee Street, Cleveland, TN 37311, NDC 67457-0340-01.
Reason: Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
D-1074-2020 April 8, 2020 Cleveland, TN