Drug and pharmaceutical recalls
17624 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2022-01-12FDA-DrugPerrigo Company PLCClass IIHealth Mart, Fexofenadine Hydrochloride tablets, 24HR, 180mg . Antihistamine 70 count bottle, Distributed by: Mckesson 6555 State Highway 161, Irvine, TX 75039. Made in the Czech Republic, NDC 62011-0233-1, UPC 0 52569 13787 1
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
- 2022-01-12FDA-DrugPerrigo Company PLCClass IIHealth Mart, Fexofenadine Hydrochloride tablets, 12HR, 60mg . Antihistamine 12 count bottle, Distributed by: Mckesson 6555 State Highway 161, Irvine, TX 75039. Made in the Czech Republic, NDC 62011-0413-1, UPC 0 52569 14278 3
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
- 2022-01-12FDA-DrugPerrigo Company PLCClass IIDG/health Aller.Ease, Fexofenadine Hydrochloride Tablets, 180 mg/Antihistamine, 24HR, 10 count bottle, Distributed by: Made in Czech Republic. Distributed by Dolgencorp, LLC, 100 Mission Ridge Goodlettsville, TN 37072. UPC 3 70030 65779 7
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
- 2022-01-12FDA-DrugPerrigo Company PLCClass IICVS Allergy Relief, Fexofenadine Hydrochloride Tablets, 60 mg Antihistamine, 12HR, packaged as a) 12 count bottle, NDC 59779-425-53, UPC 0 50428 25414 1; b)24 count bottle, NDC 59779-425-62, UPC 0 50428 53435 9; Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895, Made in Czech Republic
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
- 2022-01-12FDA-DrugPerrigo Company PLCClass IICAREONE Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg Antihistamine, 24HR, packaged as a)30 count bottle, NDC 41520-229-39, UPC 3 41520 31984 6; b)45 count bottle, NDC 41520-229-95 UPC 3 41520 31983 9; Made in the Czech Republic, Distributed by: Foodhold U.S.A. LLC Landover, MD 20785. Made in Czech Republic
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
- 2022-01-12FDA-DrugPerrigo Company PLCClass IIberkley jensen, ALLERGY RELIEF, Fexofenadine Hydrochloride Tablets, 180 mg Antihistamine, 24HR, 150 count bottle, Made in the Czech Republic, Distributed by: BJ's WHolesale Club 25 Research Drive Westborough, MA 01581
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
- 2022-01-12FDA-DrugPerrigo Company PLCClass IIbasic+care, allergy Fexofenadine Hydrochloride Tablets, 60 mg/Antihistamine, 12HR, 100 count bottle, Made in the Czech Republic, Distributed by: Perrigo Allergan, MI 49010, NDC 0113-7425-78 UPC 3 70030 14536 2
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
- 2022-01-12FDA-DrugPerrigo Company PLCClass IIbasic+care, allergy Fexofenadine Hydrochloride Tablets, 180 mg/Antihistamine, 24 HR, 150 count bottle, Made in the Czech Republic, Distributed by: Perrigo Allergan, MI 49010, NDC 0113-7571-47 UPC 3 70030 11470 2
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
- 2022-01-12FDA-DrugPerrigo Company PLCClass IIamazon, Allergy Fexofenadine Hydrochloride Tablets, 180 mg/Antihistamine, 24 HR, 30 count bottle, Made in the Czech Republic, Distributed by: Amazon.com Services LLC 410 Terry Avenue N. Seattle, WA 98109 UPC 3 70030 11466 5
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
- 2022-01-12FDA-DrugPerrigo Company PLCClass IIGoodSense 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.
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
- 2022-01-12FDA-DrugPerrigo Company PLCClass IIEQUALINE 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.
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
- 2022-01-12FDA-DrugULTRAtab Laboratories, Inc.Class IIPAIN AID ESF- (Acetaminopehn USP 250mg, Asprin USP 250mg Caffeine 65mg) coated, bulk OTC tablets packaged in corrugated boxes lined with 2 polyethylene bags 100 lb, ULTRAtab Laboratories, Inc. NDC# 62959-560-00, Product Code M560L
CGMP Deviations: failed stability results, inadequate laboratory investigations,
- 2022-01-12FDA-DrugLupin Pharmaceuticals Inc.Class IIIGatifloxacin Ophthalmic Solution, 0.5%, 2.5 mL bottle, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, INDIA, NDC 68180-435-01.
Failed Stability Specifications: Out-of-specification results observed in a water loss test that might affect the assay content and alter drug concentration.
- 2022-01-05FDA-DrugValisa MFG LLCClass Ikleantouch 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
Marketed Without an Approved NDA/ANDA: Product labeled to contain methanol making it an unapproved new drug and contains methanol
- 2022-01-05FDA-DrugSterRx, LLCClass IISodium Bicarbonate in 5% Dextrose Injection, Rx Only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-326-03
Lack of Assurance of Sterility
- 2022-01-05FDA-DrugSterRx, LLCClass IIPHENYLephrine 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.
Lack of Assurance of Sterility
- 2022-01-05FDA-DrugSterRx, LLCClass IIPHENYLephrine 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.
Lack of Assurance of Sterility
- 2022-01-05FDA-DrugSterRx, LLCClass IINOREPINEPHRINE, 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.
Lack of Assurance of Sterility
- 2022-01-05FDA-DrugSterRx, LLCClass IINOREPINEPHRINE, 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.
Lack of Assurance of Sterility
- 2022-01-05FDA-DrugSterRx, LLCClass IINOREPINEPHRINE, 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.
Lack of Assurance of Sterility
- 2022-01-05FDA-DrugSterRx, LLCClass IINOREPINEPHRINE, 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.
Lack of Assurance of Sterility
- 2022-01-05FDA-DrugSterRx, LLCClass IIMORPHINE 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.
Lack of Assurance of Sterility
- 2022-01-05FDA-DrugSterRx, LLCClass IIFentanyl 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.
Lack of Assurance of Sterility
- 2022-01-05FDA-DrugSterRx, LLCClass IIFentanyl 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.
Lack of Assurance of Sterility
- 2022-01-05FDA-DrugSterRx, LLCClass IIdilTIAZem 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.
Lack of Assurance of Sterility
- 2022-01-05FDA-DrugSterRx, LLCClass IINOREPINEPHRINE 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.
Lack of Assurance of Sterility
- 2022-01-05FDA-DrugSterRx, LLCClass IIMorphine 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.
Lack of Assurance of Sterility
- 2022-01-05FDA-DrugSterRx, LLCClass IIMidazolam 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.
Lack of Assurance of Sterility
- 2022-01-05FDA-DrugSterRx, LLCClass IIEPINEPHrine 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.
Lack of Assurance of Sterility
- 2022-01-05FDA-DrugSterRx, LLCClass IIEPINEPHIrine 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.
Lack of Assurance of Sterility
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