Drug and pharmaceutical recalls
17747 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2015-07-22FDA-DrugHospira Inc.Class IIKETOROLAC Tromethamine Inj., USP, 30 mg (30 mg/mL), 1 mL Fill, Single-dose Vials, I.V/I.M. USE, Hospira, Inc., Lake Forest, IL 60045 --- NDC 0409-3795-01 --- Also labeled under NOVAPLUS label NDC 0409-3795-49
Crystallization; identified as calcium salt of Ketorolac
- 2015-07-22FDA-DrugHospira Inc.Class II0.9% Sodium Chloride Injection USP, 50 mL ADD-Vantage Unit, Rx only, Manufactured by Hospira, Inc., Ausitn, TX 78728, NDC 00409-7101-68
Lack of assurance of sterility: Potential channel leaks near the threaded vial port.
- 2015-07-22FDA-DrugQualitest PharmaceuticalsClass IIIHydrOXYzine Hydrochloride Tablets, USP 25 mg, Rx only, 100 count (NDC 0603-3968-21), 500 count (NDC 0603-3968-28) and 1000 count (NDC 0603-3968-32) bottles, Manufactured for Qualitest Pharmaceuticals, Huntsville, AL
Failed Tablet/Capsule Specifications; The identification codes on some tablets may be unreadable
- 2015-07-22FDA-DrugGeritrex CorpClass IIICarb-O-Philic 40 Cream, 40%, a) 3 oz. tube (NDC 54162-640-03) b) 7 oz. tube (NDC 54162-640-07), Rx Only, Manufactured by Geritrex Corporation, Mount Vernon, NY 10550
CGMP Deviation: Poor container closure of the bulk storage container
- 2015-07-22FDA-DrugKremers Urban Pharmaceuticals, Inc.Class IINitroglycerin Transdermal System 0.4 mg/hr (18 cm2), For Transdermal Use Only, 30 Systems (patches) per box, Rx Only, Manufactured for: Kremers Urban Pharmaceuticals Inc., Princeton, NJ, 08540, USA, By LTS Lohmann Therapie Systeme AG, Anderach, Federal Republic of Germany, NDC 62175-124-01
Failed Impurities/Degradation Specifications: Two lots failed specification for unknown impurity at the 24 month stability testing.
- 2015-07-22FDA-DrugKremers Urban Pharmaceuticals, Inc.Class IINitroglycerin Transdermal System 0.2 mg/hr (10 cm2), For Transdermal Use Only, 30 Systems (patches) per box, Rx Only, Manufactured for: Kremers Urban Pharmaceuticals Inc., Princeton, NJ, 08540, USA, By LTS Lohmann Therapie Systeme AG, Anderach, Federal Republic of Germany, NDC 62175-123-01
Failed Impurities/Degradation Specifications: failed specification for unknown impurity at the 24 month stability testing.
- 2015-07-22FDA-DrugAmerican Health PackagingClass IIIDesmopressin Acetate Tablets, 0.1 mg Tablets, Rx Only, Packed in 30 Tablet (3 x 10) Cartons. Packaged and Distributed by: American Health Packaging Columbus, Ohio 43217. NDC: 68084-606-21.
Tablets/Capsules Imprinted with Wrong ID: Some tablets incorrectly imprinted with an X on one side.
- 2015-07-22FDA-DrugFresenius Kabi USA, LLCClass IIRifampin for Injection, USP 600mg/vial in a 20mL vial, Rx only, Manufactured for Fresenius Kabi LLC 3 Corporate Drive, Lake Zurich, IL, 60047, by Fresenius Kabi LLC, 2020 N Ruby Street, Melrose Park, IL 60160. NDC 63323-351-20
Failed Impurities/Degradation Specifications; out-of-specification for color, impurity, and degradation
- 2015-07-15FDA-DrugBioComp Pharma, Inc.Class IIIMaximum Strength Analgesic Thera-Gesic Pain Relieving Creme Relief from: Joint and Muscle Soreness, Arthritis, Back Aches; 1/8 Oz Sachet, OTC, Manufactured for Mission Pharmacal Company 10999 IH 10 West, Suite 1000 San Antonio, TX 78230 by Mission Pharmacal Company 38505 IH 10 West Boerne, TX 78006. NDC 0178-0320-12
Subpotent Drug: menthol and methyl salicylate below specification
- 2015-07-15FDA-DrugHospira Inc.Class IIIMagnesium Sulfate Injection, USP, 50%, 20mL, Single dose Fliptop Vial, For IV or IM use, Rx only, Manufactured by Hospira, Inc. 4285 Wesleyan Blvd Rocky Mount, NC 27804 for Hospira, Inc. 275 N Field Drive, Lake Forest, IL 60045. NDC 0409-2168-02
Failed pH Specifications: 12 month stability testing
- 2015-07-15FDA-DrugAbrams Royal Pharmacy II, LLCClass IIICORTISOL-MC, 10mg CAP, packaged in 30 and 90 count bottles, Rx Only, ABRAMS ROYAL pharmacy II, 4909 W Park Blvd, Suite 177, Plano, TX 75093 --- NDC 88888-0043-31
Failed Content Uniformity Specifications: Failed Uniformity of Dosage Units specifications.
- 2015-07-15FDA-DrugAmerican Health PackagingClass IIZonisamide capsules, USP 100mg packaged in 10-count blisters (NDC 68084-008-11); 5 blister packs per carton (NDC 68084-008-65); Rx only, Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA for American Health Packaging 2550-A John Glenn Avenue, Columbus, OH 43217.
CGMP Deviations: Firm did not adequately investigate customer complaints.
- 2015-07-15FDA-DrugAmerican Health PackagingClass IILisinopril tablets, USP 40mg packaged in 10-count blisters (NDC 68084-064-11); 10 blister packs per carton (NDC 68084-064-01); Rx only, Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA for American Health Packaging 2550-A John Glenn Avenue, Columbus, OH 43217.
CGMP Deviations: Firm did not adequately investigate customer complaints.
- 2015-07-15FDA-DrugAmerican Health PackagingClass IILisinopril tablets, USP 20mg packaged in 10-count blisters (NDC 68084-062-11); 10 blister packs per carton (NDC 68084-062-01); Rx only, Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA for American Health Packaging 2550-A John Glenn Avenue, Columbus, OH 43217.
CGMP Deviations: Firm did not adequately investigate customer complaints.
- 2015-07-15FDA-DrugAmerican Health PackagingClass IILisinopril tablets, USP 10mg packaged in 10-count blisters (NDC 68084-061-11); 10 blister packs per carton (NDC 68084-061-01); Rx only, Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA for American Health Packaging 2550-A John Glenn Avenue, Columbus, OH 43217.
CGMP Deviations: Firm did not adequately investigate customer complaints.
- 2015-07-15FDA-DrugAmerican Health PackagingClass IILisinopril tablets, USP 5mg packaged in 10-count blisters (NDC 68084-060-11); 10 blister packs per carton (NDC 68084-060-01); Rx only, Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA for American Health Packaging 2550-A John Glenn Avenue, Columbus, OH 43217.
CGMP Deviations: Firm did not adequately investigate customer complaints.
- 2015-07-15FDA-DrugAmerican Health PackagingClass IIFamotidine tablets, USP 20mg, packaged in 10-count blisters (NDC 68084-172-11); 10 blister packs per carton (NDC 68084-172-01); Rx only, Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA for American Health Packaging 2550-A John Glenn Avenue, Columbus, OH 43217.
CGMP Deviations: Firm did not adequately investigate customer complaints.
- 2015-07-15FDA-DrugAmerican Health PackagingClass IIClarithromycin tablets, USP 500mg, packaged in 10-count blisters (NDC 68084-437-11); 5 blister packs per carton (NDC 68084-279-65); Rx only, Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA for American Health Packaging 2550-A John Glenn Avenue, Columbus, OH 43217.
CGMP Deviations: Firm did not adequately investigate customer complaints.
- 2015-07-15FDA-DrugAmerican Health PackagingClass IIAzithromycin tablets, USP 250mg, packaged in 10-count blisters (NDC 68084-278-11); 10 blister packs per carton (NDC 68084-278-01); Rx only, Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA for American Health Packaging 2550-A John Glenn Avenue, Columbus, OH 43217.
CGMP Deviations: Firm did not adequately investigate customer complaints.
- 2015-07-15FDA-DrugAmerican Health PackagingClass IIAzithromycin tablets, USP 600mg, packaged in 10-count blisters (NDC 68084-464-11); 3 blister packs per carton (NDC 68084-464-21); Rx only, Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA for American Health Packaging 2550-A John Glenn Avenue, Columbus, OH 43217.
CGMP Deviations: Firm did not adequately investigate customer complaints.
- 2015-07-15FDA-DrugAmerican Health PackagingClass IIAzithromycin tablets, USP 500mg, packaged in 10-count blisters (NDC 68084-279-11); 3 blister packs per carton (NDC 68084-279-21); Rx only, Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA for American Health Packaging 2550-A John Glenn Avenue, Columbus, OH 43217.
CGMP Deviations: Firm did not adequately investigate customer complaints.
- 2015-07-15FDA-DrugAmerican Health PackagingClass IIAmlodipine besylate tablets, USP 10 mg, packaged in 10-count blisters (NDC 68084-506-11); 10 blister packs per carton (NDC 68084-506-01); Rx only, Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA for American Health Packaging 2550-A John Glenn Avenue, Columbus, OH 43217.
CGMP Deviations: Firm did not adequately investigate customer complaints.
- 2015-07-15FDA-DrugAmerican Health PackagingClass IIAmlodipine besylate tablets, USP 5mg, packaged in 10-count blisters (NDC 68084-505-11); 10 blister packs per carton (NDC 68084-505-01); Rx only, Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA for American Health Packaging 2550-A John Glenn Avenue, Columbus, OH 43217.
CGMP Deviations: Firm did not adequately investigate customer complaints.
- 2015-07-15FDA-DrugAmerican Health PackagingClass IIAmlodipine besylate tablets, USP 2.5mg, packaged in 10-count blisters (NDC 68084-498-11); 10 blister packs per carton (NDC 68084-498-01); Rx only, Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA for American Health Packaging 2550-A John Glenn Avenue, Columbus, OH 43217.
CGMP Deviations: Firm did not adequately investigate customer complaints.
- 2015-07-15FDA-DrugMylan Pharmaceuticals IncClass IICapecitabine Tablets, USP, 500 mg, 120-count bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505, NDC 0378-2512-78, UPC 3 0378-2512-78 6.
Failed Dissolution Specifications: low out-of-specification (OOS) results for dissolution were obtained at the nine-month stability point.
- 2015-07-15FDA-DrugHospira Inc.Class IBupivacaine Hydrochloride Inj., USP, 0.5% (5 mg/mL), Preservative-Free, 30 mL Single Use Vials, Rx only. HOSPIRA, INC., LAKE FOREST, IL 60045 USA. NDC: 0409-1162-02.
Presence of Particulate Matter: Presence of free-floating and embedded iron oxide particles.
- 2015-07-15FDA-DrugApotex Inc.Class IIEnalapril maleate and hydrochlorothiazide tablets USP, 10/25 mg, 100-count bottle, Rx only, Manufactured for Apotex Inc 150 Signet Drive, ON M9L1T9 by Apotex Research Private Limited, Plot 1 & 2, Bommasandra Industrial Area, 4th Phase Jigani Link Road, Bangalore, Karnataka, 560099, India, NDC 60505-0209-1
Failed Content Uniformity Specifications: The product may not meet the limit for blend uniformity specification.
- 2015-07-15FDA-DrugApotex Inc.Class IILosartan potassium tablets USP, 50 mg, 90-count bottle, Rx only, Manufactured for Apotex Inc 150 Signet Drive, ON M9L1T9 by Apotex Research Private Limited, Plot 1 & 2, Bommasandra Industrial Area, 4th Phase Jigani Link Road, Bangalore, Karnataka, 560099, India NDC 60505-3161-9
Failed Content Uniformity Specifications: The product may not meet the limit for blend uniformity specification.
- 2015-07-15FDA-DrugApotex Inc.Class IILosartan potassium tablets USP, 100 mg, 90-count bottle, Rx only, Manufactured for Apotex Inc 150 Signet Drive, ON M9L1T9 by Apotex Research Private Limited, Plot 1 & 2, Bommasandra Industrial Area, 4th Phase Jigani Link Road, Bangalore, Karnataka, 560099, India NDC 60505-3162-9
Failed Content Uniformity Specifications: The product may not meet the limit for blend uniformity specification.
- 2015-07-15FDA-DrugApotex Inc.Class IILosartan potassium tablets USP, 25 mg, 90- count bottle, Rx only, Manufactured for Apotex Inc 150 Signet Drive, ON M9L1T9 by Apotex Research Private Limited, Plot 1 & 2, Bommasandra Industrial Area, 4th Phase Jigani Link Road, Bangalore, Karnataka, 560099, India NDC 60505-3160-9
Failed Content Uniformity Specifications: The product may not meet the limit for blend uniformity specification.
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