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.
- 2022-01-19FDA-DrugExela Pharma Sciences LLCClass II8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL), 50 mL vials, Rx Only, Manufactured and Distributed by: Exela Pharma Sciences, LLC., Lenoir, NC 28645, NDC 51754-5001-1
Lack of Assurance of Sterility
- 2022-01-19FDA-DrugAkorn, Inc.Class IIIOxycodone Hydrochloride Oral Solution, USP 5 mg per 5 mL (1 mg/mL), 500 mL bottle, Rx only, Manufactured by: Hi-Tech Pharmacal Co., Inc., Amityville, NY 11701 --- NDC 50383-961-34
Labeling: Missing Label
- 2022-01-19FDA-DrugAkorn, Inc.Class IIIMorphine Sulfate Oral Solution 100 mg per 5 mL (20 mg/mL) 30 mL bottles, Rx only, Hi-Tech Pharmacal Co., Inc., Amityville, NY 11701 -- NDC 50383-965-30
Labeling: Missing Label
- 2022-01-19FDA-DrugRemedyRepack Inc.Class IIMetformin 750 mg Extended Release NDC # 70518-2920-00
CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
- 2022-01-19FDA-DrugTorrent Pharma Inc.Class IICarbamazepine Tablets, USP 200 mg 100 Tablets Rx only NDC 13668-268-01 Manufactured by: Torrent Pharmaceuticals Ltd. Bharuch-392130, India Manufactured for: Torrent Pharma Inc., Basking Ridge, NJ 07920.
Failed Dissolution Specifications
- 2022-01-19FDA-DrugRevive Personal Products CompanyClass IIThe Natural Dentist Healthy Balance Peppermint Sage, Menthol 0.12%, 16.9 FL OZ (500 mL) bottles, Manufactured for Revive Personal Products Company, Madison, NJ 07940, UPC 7 14132 00071 4
Labeling; Label mix-up and Wrong Bar Code; back label incorrectly states active ingredient as Menthol with UPC 7 14132 00071 4 instead of Peppermint Oil and Sage Oil with UPC 7 14132 00073 8
- 2022-01-19FDA-DrugRubicon Research Private LimitedClass IIMetoprolol Tartrate Tablets, USP 25 mg, 1000 - count bottle, Rx Only, Distributed by: TruPharma, LLC. Tampa, FL 33609; Manufactured by: Rubicon Research Prvate Limited Ambernath, Dist. Thane, 421506 India. NDC 52817-360-00
Complaint received of foreign matter (metal) embedded in tablet.
- 2022-01-12FDA-DrugSUN PHARMACEUTICAL INDUSTRIES INCClass IIPregabalin Capsules, 50 mg, 100 count bottle, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd., Survey No. 259/15 Dadra-396 191, (U.T. of D & NH), India, NDC 47335-687-88.
Failed Tablet/Capsule Specifications: Out of Specification results for particle Size Distribution and Bulk Density of the Active Pharmaceutical Ingredient.
- 2022-01-12FDA-DrugRemedyRepack Inc.Class IICefixime 400 mg capsule, packaged in a) 2-count bottle (NDC 70518-2749-02), b) 2-count blister pack (NDC 70518-2749-03), Rx only, MFG: Ascend Labs, LLC, Montvale, NJ 07645
Failed Impurities/Degradation Specifications
- 2022-01-12FDA-DrugAscend Laboratories, LLCClass IICefixime Capsules, 400 mg, 50-count bottles, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ, NDC 67877-584-50
Failed impurities/degradation specifications
- 2022-01-12FDA-DrugLupin Pharmaceuticals Inc.Class IIIOxycodone Hydrochloride Tablets, USP C-II, 5 mg, 100 count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202. Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873. NDC 43386-432-01
Out-of-specification impurity test result observed at 18-month long term stability time point.
- 2022-01-12FDA-DrugPerrigo Company PLCClass IIGoodSense Aller.Ease, Fexofenadine hydrochloride 24 HR, 180 mg tablets, 30 count bottle, Made in the Czech Republic, Distributed by Perrigo Allergan MI., 49010, UPC 3 0113 0571 39 3; NDC 0113-0571-30,
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, 180 mg Antihistamine, 24HR, 30 count bottle, NDC 69842-698-39, UPC 0 50428 62564 4
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
- 2022-01-12FDA-DrugPerrigo Company PLCClass IIKIRKLAND ALLER-FEX, Fexofenadine Hydrochloride Tablets, 180 mg/Antihistamine, 24HR, 180 count bottle, Made in the Czech Republic, Packaged by Perrigo 515 Eastern Ave., Allegan, MI 49010, For Costco Wholesale Corporation. P.O. Box 34535 Seattle, WA 98124-1535, NDC 63981-571-48, UPC 0 96619 98776 4
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
- 2022-01-12FDA-DrugPerrigo Company PLCClass IIamazon basic+care, Allergy Fexofenadine Hydrochloride Tablets, 60 mg/Antihistamine, 12HR, 100 count bottle, Made in the Czech Republic, Distributed by: Amazon.com services LLC 410 Terry Avenue N., Seattle WA 98109, NDC 72288-425-78 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 IIWal-Fex Fexofenadine Hydrochloride tablets, 60mg/antihistamine, 12HR, 24 count bottle, Distributed by Walgreen Co. 200 Wilmot Rd Deerfield IL 60015, Made in the Czech Republic, NDC 0363-0903-62 UPC 3 11917 18625 2
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
- 2022-01-12FDA-DrugPerrigo Company PLCClass IIWal-Fex Fexofenadine Hydrochloride tablets, 180mg/antihistamine, 24HR, packaged as a) 5 count bottle, NDC 0363-0600-13,UPC 3 11917 12267 0, b)30 count bottle, NDC 0363-0600-39 UPC 3 11917 16172 3 c) 90 count bottle, NDC 0363-0600-75 UPC 3 11917 12271 7 ; Distributed by Walgreen Co. 200 Wilmot Rd Deerfield IL 60015, Made in the Czech Republic,
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
- 2022-01-12FDA-DrugPerrigo Company PLCClass IIup&up allergy relief, Fexofenadine Hydrochloride tablets, 24HR, 180mg/antihistamine, packaged as a) 15 count bottle, NDC 11673-571-22 UPC 3 70030 62303 7; b) 30 count bottle, NDC 11673-571-39 UPC 3 70030 62301 3; Distributed by Target Corp., Mpls., MN 55403, Made in the Czech Republic,
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
- 2022-01-12FDA-DrugPerrigo Company PLCClass IITopCare Allergy Relief, Fexofenadine Hydrochloride tablets, 24HR, 180mg Antihistamine, packaged as a) 5 count bottle, NDC 36800-319-13 UPC 0 36800 33277-5 b) 15 count bottle, NDC 36800-319-22 UPC 0 36800 33278 2; c) 45 count bottle, NDC 36800-319-95 UPC 0 36800 33280-5; d) 90 count bottle, NDC 36800-319-75 UPC 0 36800 33282 9; Distributed Topco Associates LC, Elk Grove Village, IL 60007, Made in the Czech Republic,
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
- 2022-01-12FDA-DrugPerrigo Company PLCClass IITopCare Allergy Relief, Fexofenadine Hydrochloride tablets, 12HR, 60mg Antihistamine, 12 count bottle, Distributed Topco Associates LC, Elk Grove Village, IL 60007, Made in the Czech Republic, NDC 36800-954-53 UPC 0 36800 33284 3
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
- 2022-01-12FDA-DrugPerrigo Company PLCClass IIRite Aid ALLERGY RELIEF Fexofenadine Hydrochloride tablets, 24HR, 180mg Antihistamine, packaged as a) 30 count bottle, NDC 11822-0571-2 UPC 0 11822 99908 3; b) 150 count bottle, NDC 11822-0571-5 UPC 0 11822 85411 5; Made in the Czech Republic, Distributed by Rite Aid 30 Hunter Lane Camp Hill PA 17011
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
- 2022-01-12FDA-DrugPerrigo Company PLCClass IIRite Aid ALLERGY RELIEF Fexofenadine Hydrochloride tablets, 12HR, 60mg Antihistamine, 24 count bottle, Made in the Czech Republic, Distributed by Rite Aid 30 Hunter Lane Camp Hill PA 17011 NDC 11822-0425-0 UPC 0 11822 85410 8
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
- 2022-01-12FDA-DrugPerrigo Company PLCClass IIPerrigo Fexofenadine Hydrochloride tablets, 12HR, 60mg Antihistamine, 100 count bottle, Made in the Czech Republic, Distributed by Perrigo Allergan, MI 49010 NDC 45802-425-78 UPC 3 45802 425 78 2
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
- 2022-01-12FDA-DrugPerrigo Company PLCClass IIPerrigo Fexofenadine Hydrochloride tablets, 24HR, 180mg Antihistamine, 100 count bottle, Made in the Czech Republic, Distributed by Perrigo Allergan, MI 49010 NDC 45802-571-78 UPC 3 45802 571 78 6
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
- 2022-01-12FDA-DrugPerrigo Company PLCClass IIallergyrelief, Fexofenadine Hydrochloride tablets, 24HR, 1800mg Antihistamine, packaged as a) 15 count bottle, NDC 56062-571-22 UPC 0 41415 38973 1; b) 45 count bottle, NDC 56062-571-95 UPC 0 41415 38773 7; Distributed by PubliX SUpermarket Inc 3300 Publix Corporate Parkway Lakeland, FL 33811, Made in the Czech Republic
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
- 2022-01-12FDA-DrugPerrigo Company PLCClass IIMeijer allergy relief, Fexofenadine Hydrochloride tablets, 24HR, 1800mg Antihistamine, packaged as a) 15 count bottle, NDC 41250-060-22 UPC 7 60236 18716 5; b) 30 count bottle, NDC 41250-060-39, UPC 7 60236 18717 2; c) 45 count bottle, NDC 41250-060-95, UPC 7 60236 18732 5; Made in the Czech Republic, Distributed by Meijer Distribution Inc, Grand Rapids, MI 49544.
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
- 2022-01-12FDA-DrugPerrigo Company PLCClass IIMAJOR, Fexofenadine Hydrochloride tablets, 12HR, 60mg Antihistamine, 100 count bottle, Distributed by Major Pharmaceuticals 17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152. Made in the Czech Republic, NDC 0904-6979-60 UPC 3 09046 97960 9
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
- 2022-01-12FDA-DrugPerrigo Company PLCClass IIKroger Allergy Relief, Fexofenadine Hydrochloride tablets, 12HR, 60mg Antihistamine, 12 count bottle, Distributed by the Kroger CO. Cincinnati, Ohio 45202. Made in the Czech Republic, NDC 30142-555-53 UPC 0 41260 35588 2
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
- 2022-01-12FDA-DrugPerrigo Company PLCClass IIH.E.B Allergy Relief, Fexofenadine Hydrochloride tablets, 24HR, 180mg/Antihistamine packaged as a) 15 count bottle, NDC 37808-571-22, UPC 0 41220 53081 6; b) 30 count bottle, NDC 37808-571-39, UPC 0 41220 53082 3; c) 45 count bottle, NDC 37808-571-95, UPC 0 41220 53083 0; Made with Pride & Care for H.E.B. San Antonio TX 78204, Product of Czech Republic,
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
- 2022-01-12FDA-DrugPerrigo Company PLCClass IIH.E.B Allergy Relief, Fexofenadine Hydrochloride tablets, 12HR, 60mg/Antihistamine 12 count bottle, Made with Pride & Care for H.E.B. San Antonio TX 78204, Product of Czech Republic, NDC 37808-425-53, UPC 0 41220 53080 9
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
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