FDA Recall
Terminated
Historical recordClass II
Compounded Plaquex, intravenous injection, 50 ML vial. Each ml contains: Phosphatidyl Choline 50 mg, Sodium Deoxycholate 25 mg, Benzyl Alcohol 0.9%, Ethanol (95%) 2.4 mg di Alpha Tocopheryl Acetate 0.2 mg in Sterile Water for injection.
by AnazaoHealth Corporation
- Reason
- Good Manufacturing Practices Deviations: The product has an active pharmaceutical ingredient from an unapproved source.
- Published
- February 18, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Children's Loratadine Syrup (Loratadine Oral Solution) 5 mg/5 mL, Antihistamine, Grape Flavored Syrup, 24 Hour Non-Drowsy Allergy Relief Sugar Free, 4 FL OZ (120 mL) Bottles, Distributed by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532. NDC: 51672-2092-8.
by Taro Pharmaceuticals U.S.A., Inc.
- Reason
- Presence of Foreign Substance: Presence of blue plastic floating in loratadine syrup.
- Published
- February 11, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
1% LIDOCAINE HCl Injection, USP, Preservative-Free, 10 mg/mL, 30 mL Single-dose vials, packaged in 25-count cartons, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-4279-02.
by Hospira Inc.
- Reason
- Presence of Particulate Matter: Confirmed customer complaint that orange and black particulates, identified as iron oxide, were found embedded within the glass vial and floating in solution.
- Published
- February 11, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Propofol Injectable Emulsion, 1%, 200 mg/20 mL, (10mg/mL), 20 mL, Single patient infusion vial, Contains Benzyl Alcohol, For I.V. Administration, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4699-30
by Hospira Inc.
- Reason
- Presence of Particulate Matter: The firm received a complaint of an embedded particulate in the neck of one vial composed primarily of iron.
- Published
- February 4, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Fluconazole Injection, USP, 200 mg/100 mL (2 mg/mL), 100 mL Single-Dose INTRAVIA Container bag, packaged in 10 x 100 mL Single Dose INTRAVIA container bags per carton, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-6046-48, Product Code 2J1446.
by Baxter Healthcare Corp.
- Reason
- Lack of Assurance of Sterility: Complaints of leaks due to an incomplete seal at the bag seam.
- Published
- February 4, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Virazole (Ribavirin for Inhalation Solution, USP), Sterile Lyophilized For Administration by Aerosol Inhalation Only, Rx only, Contents: Four 6 g vials, 100 mL, Distributed by: Valeant Pharmaceuticals North America, Bridgewater, NJ 08807 USA, NDC 0187-0007-14.
by Valeant Pharmaceuticals North America LLC
- Reason
- Non-Sterility: Valeant's laboratory observed a positive microbial contamination of Virazole lot 340353F, during testing at the 12 month stability pull.
- Published
- January 28, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
LAMOTRIGINE TABLETS, 200 mg, 100 Tablets (10 tablets per blister card x 10 blister cards per carton), Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV --- NDC 51079-866-20
by Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
- Reason
- CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices
- Published
- January 28, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
CIPROFLOXACIN TABLETS, USP, 500 mg, 100 Tablets (10 tablets per blister card. 10 blister cards per carton), Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV --- NDC 51079-182-20.
by Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
- Reason
- CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices
- Published
- January 28, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
3M ESPE Clinpro 5000 (1.1% Sodium Flouride), Anti-Cavity Toothpaste, 4 oz tube (NDC 48878-3130-04), Rx Only, Manufactured for 3M ESPE Dental Products, St. Paul, MN 55144
by 3M Company/3m Espe Dental Products
- Reason
- Labeling: Incorrect or Missing Lot and/or Exp. Date - The subject lot is missing the lot number and expiration date stamp on the primary box..
- Published
- January 28, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
0.9% Sodium Chloride Injection, USP, 100mL, VisIV Container, Rx only, Hospira Inc., Lake Forest, IL 60045, NDC 0409-7984-11
by Hospira Inc.
- Reason
- Lack of Assurance of Sterility: The product has the potential for solution to leak at the administrative port.
- Published
- January 14, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Triamcinolone Acetonide Lotion USP, 0.025% is supplied in the following size: 60 mL (NDC 61748-219-60).
by Akorn, Inc.
- Reason
- Failed Impurities/Degradation Specifications: The known impurity went out of specification at 12 months stability point.
- Published
- January 14, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
HydrALAZINE Hydrochloride Tablets, USP 25 mg, 100 count bottle Rx only, Distributed by: Par Pharmaceutical Companies, Inc. Spring Valley, NY10977
by Par Pharmaceutical Inc.
- Reason
- Presence of Foreign Substance: Par Pharmaceutical, Inc. is recalling one lot of HydrALAZINE Hydrochloride tablets due to the presence of small aluminum particles.
- Published
- January 14, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
ACETAMINOPHEN and CODEINE PHOSPHATE ORAL SOLUTION USP, 120 mg/12 mg per 5 mL, packaged in a) 4 oz. (120 mL) bottles, NDC 0603-9013-54, UPC 3 0603-9013-54 8 and b) ONE PINT (473 mL) bottles, NDC 0603-9013-58, UPC 3 0603-9013-58 6, Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811
by Qualitest Pharmaceuticals
- Reason
- Failed Impurities/Degradation Specifications: High out of specification results for the known impurity p-Aminophenol.
- Published
- January 14, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Gabapentin Capsules, USP 300 mg, 100-count bottles, Rx only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141; Manufactured by: Aurobindo Pharma Limited, Unit-VII (SEZ), Mahaboob Nagar (Dt), AP-509302, INDIA, NDC 16714-662-01, UPC 3 16714-662-01 5.
by Aurobindo Pharma USA Inc
- Reason
- Failed Tablet/Capsule Specifications: Complaints of empty capsules received.
- Published
- January 14, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
GINSENG KIANPI PIL, 60 capsules, PRODUCT OF KWEILIN DRUG MANUFACTORY
by One and Zen
- Reason
- Marketed Without An Approved NDA/ANDA: FDA analysis found this product to contain undeclared dexamethasone and cyproheptadine which are FDA approved drugs making this product an unapproved drug.
- Published
- January 7, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Alprazolam tablets, USP, CIV, 0.25 mg, Rx Only, a) 500 count bottle, b) 1000 count bottle, Distributed by: Greenstone LLC, Peapack, NJ, 07977, a) NDC 59762-3719-3, b) NDC 59762-3719-4.
by Neolpharma, Inc.
- Reason
- Subpotent Drug
- Published
- December 31, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Benzonatate Capsules, USP, 100 mg, Rx only, Manufactured by: Cadila Healthcare Ltd, Ahmedabad, India; Distributed by: Zydus Pharmaceuticals USA, In, Pennington, NJ USA 08534; 100-bottle capsules - NDC 68382-247-01 500-bottle capsules - NDC 68382-247-05
by Zydus Pharmaceuticals USA Inc
- Reason
- Failed Tablet/Capsule Specifications: Recall due to wet and/or leaking capsules.
- Published
- December 31, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
HEPARIN SODIUM, 1000 USP Heparin Units/500 mL (2 USP Heparin Units/mL), in 0.9% Sodium Chloride Injection, 500 mL flexible container unit, Rx only, Hospira Inc., Lake Forest, IL 60045, NDC 0409-7620-03
by Hospira Inc.
- Reason
- Presence of Particulate Matter: A particulate, confirmed as human hair, was found sealed between the tube and film at the round seal of the unused administrative port of the container.
- Published
- December 31, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Eye Drops Advanced Relief (Dextran 70 0.1%, Polyethylene glycol 400 1%, Povidone 1%, Tetrahydrozoline HCl 0.05%), 0.5 FL OZ (15 mL) Bottles, Over the Counter. Labeled: a) Advanced Relief, Distributed by Safeway Inc., P.O.Box 99, Pleasanton, CA 94566-0009, UPC: 3 21130 70064 7; b) Best Choice, Distributed By: Valu Mercahndisers, Co., 5000 Kansas Ave, Kansas City, KS 66106, UPC: 0 70038 47009 0; c) EQUALINE, Distributed By Supervalu Inc., Eden Prairie, MN 55344, UPC: 0 41163 25392 6; d) equate, Manufactured for/Fabrique pour: Wal-Mart Canada Corp, 1940 Argentia Rd, Mississauga Ontario L5N 1P9, Imported by/ Importe par: Arrow OTC Company, Mississauga, Ontario L5N 2B8, UPC: 1 83164 00022 9; e) exchange select, Manufactured For: Your Military Exchanges By: KC Pharmaceuticals, Inc., Pomona, CA 91768, UPC: 6 14299 39625 8; f) GOOD NEIGHBOR PHARMACY, Distributed By AmerisourceBergen 1300 Morris Drive, Chesterbrook, PA 19087, UPC: 0 87701 10663 7, NDC: 24385-077-05; g) GOODSENSE, Manufactured By: KC Pharmaceuticals, Pomona, CA 91768, UPC: 1 80410 00019 4, NDC: 48879-007-07; h) H-E-B, Made for H-E-B, San Antonio, TX 78204, UPC: 0 41220 89137 5; i) Health Mart, Distributed by McKesson, One Post Street, San Francisco, CA 94104, UPC: 0 52569 13474 0, NDC: 62011-0104-1; j) healthy accents, Distributed by: DZA Brands, LLC, 2110 Executive Drive, Salisbury, NC 28147, NDC: 7 25439 93383 4; k) HyVee, Distributed By Hy-Vee, Inc., 5820 Westown Parkway, West Des Moines, IA 50266, UPC: 0 75450 29778 2; l) Kroger, Distributed by The Kroger Co., Ohio 45202, UPC: 0 11110 38598 7; m) life, Imported for/ Importe pour: SHOPPERS DRUG MART PHARMAPRIX, Toronto, M2J 4W8, by/par: Arrow OTC Inc., Mississauga, Ontario L5N 2B8, UPC: 0 57800 15640 6; n) LiveBetter, Distributed by Onpoint, Inc., 2 Paragon Drive, Montvale, NJ 07645, UPC: 0 41310 62043 4; o) Medic's Choice, KC Pharmaceuticals, Inc., Pomona, CA 91768, UPC: 0 95072 01251 8, NDC: 055654-025; p) meijer, Dist. By Meijer Distribution, Inc., 2929 Walker Ave NW, Grand Rapids, MI 49544, UPC: 0 41250 82917 1; q) Our Family, Distributed by NASH FINCH COMPANY, NFC Brands, 7600 France Ave S, MPLS 55435, UPC: 0 70253 96683 5; r) Publix, Distributed by Publix Super Markets, Inc., 3300 Publix Corporate Parkway, Lakeland, FL 33811, UPC: 0 41415 06776 9; s) Rexall, Manufactured for: Rexall Brands Corp., Mississauga, Ontario L5N 2B8, Imported by: Arrow OTC Company, Mississauga, Ontario L5N 2B8, UPC: 7 71058 10462 8; t) Rexall, Fabrique pour: Rexall Brands Corp., Mississauga, Ontario L5N 2B8, Importe par: Arrow OTC Company, Mississauga, Ontario L5N 2B8, UPC: 7 71058 10462 8; u) select brand, Distributed by: SELECT BRAND DISTRIBUTORS, Pine Bluff, AR 71603, UPC: 0 15127 00364 3; v) sunmark, Distributed By McKesson, One Post Street, San Francisco, CA 94104, UPC: 0 10939 16833 7, NDC: 49348-697-29; w) TopCare, Distributed by Topco Associates LLC, 7711 Gross Point Road, Skokie, IL 60077, UPC: 0 36800 03641 3; x) WESTERN FAMILY, Distributed by Western Family Foods, Imc., P.O.Box 4057, Portland OR 97208, UPC: 0 15400 03281 0.
by K C Pharmaceuticals Inc
- Reason
- CGMP Deviations: Active Pharmaceutical Ingredient (API) used for manufacture was stored in a non-GMP compliant warehouse at S.I.M.S., Italy.
- Published
- December 31, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Eye Drops Industrial Strength (Polyethylene glycol 400 1%, Tetrahydrozoline HCl 0.05%), 0.5 FL OZ (15 mL) Bottles, Over the Counter. Labeled: a) Manufactured for: Petragon, Inc., Edwardsville, KS 66111; b) SWIFT, Distributed by Swift First Aid, Inc., Valencia, Calif. 91355, UPC: 6 69635 24082 5; c) Xpect First aid, Manufactured for Cintas First Aid & Safety, Mason, OH 45040; d) ZEE, Distributed by ZEE MEDICAL, INC., Irvine, CA 92606, UPC: 6 90689 00609 9.
by K C Pharmaceuticals Inc
- Reason
- CGMP Deviations: Active Pharmaceutical Ingredient (API) used for manufacture was stored in a non-GMP compliant warehouse at S.I.M.S., Italy.
- Published
- December 31, 2014
- 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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