FDA Recall
TerminatedTerminated: September 22, 2016Historical recordClass II
HCG (Lyophilized) Injectable, 5000 units/vial, 5mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
by Downing Labs, LLC
- Reason
- Lack of Assurance of Sterility
- Published
- November 25, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: September 22, 2016Historical recordClass II
Methylcobalamin Buffered Injectable, 5mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
by Downing Labs, LLC
- Reason
- Lack of Assurance of Sterility
- Published
- November 25, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: September 22, 2016Historical recordClass II
Phosphatidylcholine/Deoxycholic Acid Injection (Preserved) 50 ML 10/4.75%; Phosphatidylcholine/Deoxycholic Acid Injection (Preserved) 50 ML 5/2.5%; Phosphatidylcholine/Deoxycholic Acid Injection (Preserved) 50 ML 5/4.2%, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
by Downing Labs, LLC
- Reason
- Lack of Assurance of Sterility
- Published
- November 25, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: September 22, 2016Historical recordClass II
Cyanocobalamin Buffered Injectable 3mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
by Downing Labs, LLC
- Reason
- Lack of Assurance of Sterility
- Published
- November 25, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: September 22, 2016Historical recordClass II
Taurine Injectable, 50mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
by Downing Labs, LLC
- Reason
- Lack of Assurance of Sterility
- Published
- November 25, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: September 22, 2016Historical recordClass II
Methylcobalamin Buffered Injectable, 1mg/mL, packaged in a) 10mL vial, b) 30mL Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
by Downing Labs, LLC
- Reason
- Lack of Assurance of Sterility
- Published
- November 25, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: September 22, 2016Historical recordClass II
Vitamin D3 Injectable, 10,000 U/mL, 10mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
by Downing Labs, LLC
- Reason
- Lack of Assurance of Sterility
- Published
- November 25, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: September 22, 2016Historical recordClass II
Co-Enzyme Q-10 Injectable, 20mg/mL, 10mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
by Downing Labs, LLC
- Reason
- Lack of Assurance of Sterility
- Published
- November 25, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: September 22, 2016Historical recordClass II
Riboflavin-5-Phosphate Injectable,10mg/mL, 10mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
by Downing Labs, LLC
- Reason
- Lack of Assurance of Sterility
- Published
- November 25, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: September 22, 2016Historical recordClass II
MICML TRNDPPC Injection (Preserved) 10mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
by Downing Labs, LLC
- Reason
- Lack of Assurance of Sterility
- Published
- November 25, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: September 22, 2016Historical recordClass II
Ascorbic Acid Injectable 500mg/mL, packaged in a) 10mL vials, b) 50mL vials, c)100mL vials, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
by Downing Labs, LLC
- Reason
- Lack of Assurance of Sterility
- Published
- November 25, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: September 22, 2016Historical recordClass II
EDTA Disodium Injectable, 150mg/mL, 100mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
by Downing Labs, LLC
- Reason
- Lack of Assurance of Sterility
- Published
- November 25, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: September 22, 2016Historical recordClass II
L-Tyrosine Injectable, 25mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
by Downing Labs, LLC
- Reason
- Lack of Assurance of Sterility
- Published
- November 25, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: September 22, 2016Historical recordClass II
L-Glutamine Injectable, 30mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
by Downing Labs, LLC
- Reason
- Lack of Assurance of Sterility
- Published
- November 25, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: October 18, 2018Historical recordClass I
KABOOM action strips, Sexual Performance Strips, packaged in 6.4oz box 12 strips per box, Nutrology USA LLC
by Blue Square Market, Inc.
- Reason
- Marketed Without An Approved NDA/ANDA: presence of undeclared Sulfoaildenafil.
- Published
- November 25, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: October 18, 2018Historical recordClass I
LiDa DAIDAIHUA (also packaged as LiDa DAIDAIHUAJIAONANG), capsules, packaged in 1.6oz box 30 capsules per box, Kunming Dali Industry & Trade Co., Ltd
by Blue Square Market, Inc.
- Reason
- Marketed Without An Approved NDA/ANDA: presence of undeclared Sibutramine and Phenolphthalein.
- Published
- November 25, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: November 29, 2017Historical recordClass III
Hydrocortisone and Acetic Acid Otic Solution, USP, containing hydrocortisone (1%) and acetic acid (2%), 10 mL bottles, Rx Only, Hi-Tech Pharmacal, Amityville, NY 11701, Made in USA, NDC # 50383-901-10
by Akorn, Inc.
- Reason
- Defective Container: Product missing safety seal around the neck of the bottle. The product label indicates, "Tamper Evident: Do not use if printed seal around cap is broken or missing." Because the product is missing the approved component and is not consistent with the labeling, the lot is being recalled.
- Published
- November 25, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: March 30, 2017Historical recordClass II
Zinc Sulfate (1 mg/mL), 10 mL Single Dose Vial, For IV Use After Dilution, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3226-07
by US Compounding Inc
- Reason
- Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
- Published
- November 25, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: March 30, 2017Historical recordClass II
Voriconazole Solution (1%(10 mg/mL), 15 mL dropper bottle; For Topical Ophthalmic Use, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-2815-10
by US Compounding Inc
- Reason
- Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
- Published
- November 25, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: March 30, 2017Historical recordClass II
Vitamin D3 in Olive Oil (50,000 IU/mL) 30 mL vial, For IM Use only, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3277-06
by US Compounding Inc
- Reason
- Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
- Published
- November 25, 2015
- Distribution
- Nationwide
View recall →
Recall records are summarized from official FDA and USDA sources. Notices may be updated, reclassified, terminated, or withdrawn. Always review the linked official notice for the most current instructions.
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