FDA Recall
TerminatedTerminated: November 8, 2022Historical recordClass II
GoodSense Aller.Ease, Fexofenadine hydrochloride 12 HR, 60 mg tablets, 24 count bottle, UPC 3 0113 0425 62 7; Made in the Czech Republic, Distributed by: Perrigo Allergan MI 49010.
by Perrigo Company PLC
- Reason
- Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
- Published
- January 12, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: November 8, 2022Historical recordClass II
EQUALINE aller-ease fexofenadine hydrochloride tablets, 180 mg, 24 HR, packaged as a) 15 count bottle, NDC 41163-571-22, UPC 0 41163 48067 4; b) 70 tablets per bottle, NDC 41163-571-01, UPC 0 41163 49847 1; Made in the Czech Republic, Distributed by: UNFI Providence, RI 02908.
by Perrigo Company PLC
- Reason
- Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
- Published
- January 12, 2022
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: September 12, 2022Historical recordClass III
Gatifloxacin Ophthalmic Solution, 0.5%, 2.5 mL bottle, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, INDIA, NDC 68180-435-01.
by Lupin Pharmaceuticals Inc.
- Reason
- Failed Stability Specifications: Out-of-specification results observed in a water loss test that might affect the assay content and alter drug concentration.
- Published
- January 12, 2022
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: February 26, 2024Historical recordClass I
kleantouch HAND SANITIZER (ethyl alcohol 70%), 8.0 FL OZ (236 ML), pump bottles, Distributed by: Valisa MFG, LLC, Farmingdale, NY, 11735, Made in USA, UPC 6 86162 99246 1
by Valisa MFG LLC
- Reason
- Marketed Without an Approved NDA/ANDA: Product labeled to contain methanol making it an unapproved new drug and contains methanol
- Published
- January 5, 2022
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: December 6, 2023Historical recordClass II
Sodium Bicarbonate in 5% Dextrose Injection, Rx Only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-326-03
by SterRx, LLC
- Reason
- Lack of Assurance of Sterility
- Published
- January 5, 2022
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: December 6, 2023Historical recordClass II
PHENYLephrine HCl, 50 mg per 250 mL, (200 mg per mL) in 0.9% Sodium Chloride Injection, Rx Only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-901-01.
by SterRx, LLC
- Reason
- Lack of Assurance of Sterility
- Published
- January 5, 2022
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: December 6, 2023Historical recordClass II
PHENYLephrine HCl, 40 mg per 250 mL, (160 mcg per mL) in 0.9% Sodium Chloride Injection, Rx Only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-252-01.
by SterRx, LLC
- Reason
- Lack of Assurance of Sterility
- Published
- January 5, 2022
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: December 6, 2023Historical recordClass II
NOREPINEPHRINE, 16 mg per 250 mL, (64 mcg per mL) in 0.9% Sodium Chloride Injection, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-926-01.
by SterRx, LLC
- Reason
- Lack of Assurance of Sterility
- Published
- January 5, 2022
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: December 6, 2023Historical recordClass II
NOREPINEPHRINE, 8 mg per 250 mL, (32 mcg per mL) in 0.9% Sodium Chloride Injection, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-676-01.
by SterRx, LLC
- Reason
- Lack of Assurance of Sterility
- Published
- January 5, 2022
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: December 6, 2023Historical recordClass II
NOREPINEPHRINE, 4 mg per 250 mL, (18 mcg per mL) in 0.9% Sodium Chloride Injection, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-651-01.
by SterRx, LLC
- Reason
- Lack of Assurance of Sterility
- Published
- January 5, 2022
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: December 6, 2023Historical recordClass II
NOREPINEPHRINE, 16 mg per 250 mL, (64 mcg per mL) in 5% Dextrose Injection, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-002-01.
by SterRx, LLC
- Reason
- Lack of Assurance of Sterility
- Published
- January 5, 2022
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: December 6, 2023Historical recordClass II
MORPHINE SULFATE, in 0.9% Sodium Chloride Injection, 50 mg per 50 mL, (1 mg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-427-01.
by SterRx, LLC
- Reason
- Lack of Assurance of Sterility
- Published
- January 5, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: December 6, 2023Historical recordClass II
Fentanyl Citrate, in 0.9% Sodium Chloride Injection, 2.5 mg per 250 mL, (10 mcg per mL), Rx Only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-327-02.
by SterRx, LLC
- Reason
- Lack of Assurance of Sterility
- Published
- January 5, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: December 6, 2023Historical recordClass II
Fentanyl Citrate, in 0.9% Sodium Chloride Injection, 1 mg per 100 mL, (10 mcg per mL), Rx Only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-327-01.
by SterRx, LLC
- Reason
- Lack of Assurance of Sterility
- Published
- January 5, 2022
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: December 6, 2023Historical recordClass II
dilTIAZem HCl in 5% Dextrose Injection, 125 mg per 125 mL, (32 mcg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-951-01.
by SterRx, LLC
- Reason
- Lack of Assurance of Sterility
- Published
- January 5, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: December 6, 2023Historical recordClass II
NOREPINEPHRINE in 5% Dextrose Injection, 8 mg per 250 mL (32 mg per mL) Injection, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-476-01.
by SterRx, LLC
- Reason
- Lack of Assurance of Sterility
- Published
- January 5, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: December 6, 2023Historical recordClass II
Morphine Sulfate in 5% Dextrose Injection, 100 mg per 100 mL (1 mg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-452-01.
by SterRx, LLC
- Reason
- Lack of Assurance of Sterility
- Published
- January 5, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: December 6, 2023Historical recordClass II
Midazolam in 0.9% Sodium Chloride Injection, 100 mg per 100 mL (1 mg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-102-02.
by SterRx, LLC
- Reason
- Lack of Assurance of Sterility
- Published
- January 5, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: December 6, 2023Historical recordClass II
EPINEPHrine in 0.9% Sodium Chloride Injection, 16 mg per 250 mL (64 mcg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-627-01.
by SterRx, LLC
- Reason
- Lack of Assurance of Sterility
- Published
- January 5, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: December 6, 2023Historical recordClass II
EPINEPHIrine in 0.9% Sodium Chloride Injection, 8 mg per 250 mL (32 mcg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-077-01.
by SterRx, LLC
- Reason
- Lack of Assurance of Sterility
- Published
- January 5, 2022
- 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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