FDA Recall
TerminatedTerminated: October 27, 2021Historical recordClass II
FENTANYL 1000MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
by Assurance Infusion
- Reason
- Lack of sterility assurance.
- Published
- January 22, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: October 27, 2021Historical recordClass II
BUP 9MG/ HYDROM 25MG/ SUF 110MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
by Assurance Infusion
- Reason
- Lack of sterility assurance.
- Published
- January 22, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: October 27, 2021Historical recordClass II
BUP 5MG/HYDROM 5MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
by Assurance Infusion
- Reason
- Lack of sterility assurance.
- Published
- January 22, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: October 27, 2021Historical recordClass II
BUP 5.3MG/ FENT 1050 MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
by Assurance Infusion
- Reason
- Lack of sterility assurance.
- Published
- January 22, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: October 27, 2021Historical recordClass II
BUP 35MG/MORP 10MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
by Assurance Infusion
- Reason
- Lack of sterility assurance.
- Published
- January 22, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: October 27, 2021Historical recordClass II
BUP 21MG/CLON 252MCG/MORP 20MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
by Assurance Infusion
- Reason
- Lack of sterility assurance.
- Published
- January 22, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: October 27, 2021Historical recordClass II
BUP 20MG/CLON 250MCG/FENT 7200MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
by Assurance Infusion
- Reason
- Lack of sterility assurance.
- Published
- January 22, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: October 27, 2021Historical recordClass II
BUP 10MG/HYDROM 15MG/SUF 200MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
by Assurance Infusion
- Reason
- Lack of sterility assurance.
- Published
- January 22, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: October 27, 2021Historical recordClass II
BUP 10MG/ FENT 1000MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
by Assurance Infusion
- Reason
- Lack of sterility assurance.
- Published
- January 22, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: October 27, 2021Historical recordClass II
BACLOFEN 2000MCG/ML (40) INJ in 20 mL syringe Assurance Infusion (713) 533-8800
by Assurance Infusion
- Reason
- Lack of sterility assurance.
- Published
- January 22, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: October 27, 2021Historical recordClass II
BAC 800MCG/BUP 6.7MG/CLON 600 MCG/FENT 850MCG/MORP 20MG INJ in 20 mL syringe Assurance Infusion (713) 533-8800
by Assurance Infusion
- Reason
- Lack of sterility assurance.
- Published
- January 22, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: October 27, 2021Historical recordClass II
BAC 250MCG/ /FENT 3500MCG/ /MORP 25MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
by Assurance Infusion
- Reason
- Lack of sterility assurance.
- Published
- January 22, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: October 27, 2021Historical recordClass II
BAC 2400MCG/ FENT 2600MCG/ MORP 3600MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
by Assurance Infusion
- Reason
- Lack of sterility assurance.
- Published
- January 22, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: October 27, 2021Historical recordClass II
BAC 160MCG/HYDROM 16MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
by Assurance Infusion
- Reason
- Lack of sterility assurance.
- Published
- January 22, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: July 14, 2021Historical recordClass II
Dutasteride Capsules, 0.5 mg, 30 Capsules (6 X 5) Unit Dose per carton, Rx Only, Manufactured for: AvKARE, Inc., Pulaski, TN 38478, NDC 50268-282-13.
by AVKARE Inc.
- Reason
- Failed Impurities/Degradation Specifications: High out of specification results for related compounds.
- Published
- January 22, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: September 28, 2022Historical recordClass III
SURE 48hr Confidence Unscented Original Solid Anti-Perspirant & Deodorant Net Wt 2.7 oz (76g) NDC# 41595-5513-2 UPC 8 83484 71794 3 Made in Canada and Distributed by Idelle Labs, Ltd., El Paso, TX 79912
by Idelle Labs
- Reason
- Labeling Product Contains Undeclared API: Active Ingredient on label is not the active ingredient in the product.
- Published
- January 15, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: September 28, 2022Historical recordClass III
SURE 48hr Confidence Regular Original Solid Anti-Perspirant & Deodorant Net Wt 2.7 oz (76g) NDC# 41595-5514-1 UPC 8 83484 717936 6 Made in Canada and Distributed by Idelle Labs, Ltd., El Paso, TX 79912
by Idelle Labs
- Reason
- Labeling Product Contains Undeclared API: Active Ingredient on label is not the active ingredient in the product.
- Published
- January 15, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: September 28, 2022Historical recordClass III
SURE 48hr Confidence Nourishing Coconut invisible solid Antiperspirant & Deodorant Net Wt 2.6 oz (73g) NDC# 41595-5547-1 UPC 8 83484 31020 5 Made in Canada and Distributed by Idelle Labs, Ltd., El Paso, TX 79912
by Idelle Labs
- Reason
- Labeling Product Contains Undeclared API: Active Ingredient on label is not the active ingredient in the product.
- Published
- January 15, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: September 28, 2022Historical recordClass III
SURE 48 hr Confidence Unscented invisible solid Anti-Perspirant & Deodorant, Net Wt. 2.6 oz (73g) NDC# 41595-5509-2 UPC 8 83484 71717 2 Made in Canada and Distributed by Idelle Labs, Ltd., El Paso, TX 79912
by Idelle Labs
- Reason
- Labeling Product Contains Undeclared API: Active Ingredient on label is not the active ingredient in the product.
- Published
- January 15, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: October 22, 2020Historical recordClass II
Blisovi Fe 1.5/30 (norethindrone acetate and ethinyl estradiol tablets USP and ferrous fumarate tablets 75mg), Rx Only, Distributed by: Lupin Pharmaceuticals Inc Baltimore, MD 21202, Manufactured for: Lupin Limited Pithampur 454775 INDIA 240875, NDC 68180-866-11
by Lupin Pharmaceuticals Inc.
- Reason
- Failed Tablet/Capsule Specifications: Complaints related to crumbling of tablets when popped out of the blister pack.
- Published
- January 15, 2020
- 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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