FDA Recall
TerminatedTerminated: July 24, 2015Historical recordClass II
Ertapenem various strength in normal saline bags
by Walgreens Infusion Services
- Reason
- Lack of sterility assurance.
- Published
- January 28, 2015
- Distribution
- Texas, Florida, Virginia, Georgia, Louis…
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FDA Recall
TerminatedTerminated: July 24, 2015Historical recordClass II
Imipenem/ cilastatin various strength in normal saline bags
by Walgreens Infusion Services
- Reason
- Lack of sterility assurance.
- Published
- January 28, 2015
- Distribution
- Texas, Florida, Virginia, Georgia, Louis…
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FDA Recall
TerminatedTerminated: July 24, 2015Historical recordClass II
Ceftazidime various strength in normal saline bags
by Walgreens Infusion Services
- Reason
- Lack of sterility assurance.
- Published
- January 28, 2015
- Distribution
- Texas, Florida, Virginia, Georgia, Louis…
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FDA Recall
TerminatedTerminated: July 24, 2015Historical recordClass II
Cefoxitin various strength in normal saline bags
by Walgreens Infusion Services
- Reason
- Lack of sterility assurance.
- Published
- January 28, 2015
- Distribution
- Texas, Florida, Virginia, Georgia, Louis…
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FDA Recall
TerminatedTerminated: July 24, 2015Historical recordClass II
Cefepime various strengths in normal saline
by Walgreens Infusion Services
- Reason
- Lack of sterility assurance.
- Published
- January 28, 2015
- Distribution
- Texas, Florida, Virginia, Georgia, Louis…
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FDA Recall
TerminatedTerminated: July 24, 2015Historical recordClass II
Aztreonam 1 gram in normal saline
by Walgreens Infusion Services
- Reason
- Lack of sterility assurance.
- Published
- January 28, 2015
- Distribution
- Texas, Florida, Virginia, Georgia, Louis…
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FDA Recall
TerminatedTerminated: July 24, 2015Historical recordClass II
Amikacin various strength in normal saline bags
by Walgreens Infusion Services
- Reason
- Lack of sterility assurance.
- Published
- January 28, 2015
- Distribution
- Texas, Florida, Virginia, Georgia, Louis…
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FDA Recall
TerminatedTerminated: July 24, 2015Historical recordClass II
Liposomal Amphotericin B 130 mg in dextrose bags
by Walgreens Infusion Services
- Reason
- Lack of sterility assurance.
- Published
- January 28, 2015
- Distribution
- Texas, Florida, Virginia, Georgia, Louis…
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FDA Recall
TerminatedTerminated: July 2, 2015Historical 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
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FDA Recall
TerminatedTerminated: January 26, 2017Historical 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
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FDA Recall
TerminatedTerminated: May 1, 2017Historical 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
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FDA Recall
TerminatedTerminated: February 1, 2016Historical 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
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FDA Recall
TerminatedTerminated: May 23, 2016Historical 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
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FDA Recall
TerminatedTerminated: March 23, 2015Historical 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
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FDA Recall
TerminatedTerminated: April 26, 2017Historical 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
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FDA Recall
TerminatedTerminated: September 22, 2017Historical 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
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FDA Recall
TerminatedTerminated: January 4, 2016Historical 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
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FDA Recall
TerminatedTerminated: October 26, 2015Historical 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
TerminatedTerminated: October 26, 2015Historical 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 →
FDA Recall
TerminatedTerminated: October 26, 2015Historical recordClass III
Eye Drops A.C. (Tetrahydrozoline HCl 0.05%, Zinc sulfate 0.25%), 0.5 FL OZ (15 mL) Bottles, Over the Counter. Labeled: a) Astringent Redness Reliever, Distributed by Safeway Inc., P.O. Box 99, Pleasanton, CA 94566-0009, UPC: 3 21130 70067 8; b) Best Choice, Distributed By: Valu Merchandisers, Co., 5000 Kansas Ave, Kansas City, KS 66106, UPC: 0 70038 47010 6; c) EQUALINE, Distributed by Supervalu Inc., Eden Prairie, MN, UPC: 0 41163 25114 4; d) GOODSENSE, Manufactured By: KC Pharmaceuticals, Pomona, CA 91768, UPC: 1 80410 00018 7, NDC: 48879-010-07; e) H-E-B, Made for: H-E-B, San Antonio, TX 78204, UPC: 0 41220 86936 7; f) healthy accents, Distributed by: DZA Brands, LLC 2110 Executive Drive, Salisbury, NC 28147, UPC: 7 25439 93382 7; g) HyVee, Distributed By Hy-Vee, Inc., 5820 Westown Parkway, West Des Moines, IA 50266, UPC: 0 75450 29777 5; h) Kroger, Distributed by The Kroger Co., Cincinnati, Ohio 45202, UPC: 0 11110 38599 4; i) life, Imported for/Importe pour: SHOPPERS DRUG MART PHARMAPRIX., Toronto, M2J 4W8, by/par: Arrow OTC Inc., Mississauga, Ontario L5N 2B8, UPC: 0 57800 19617 4; j) LiveBetter, Distributed By Onpoint. Inc., 2 Paragon Drive, Montvale, NJ 07645, UPC: 0 41310 62041 0; k) meijer, Dist. by Meijer Distribution, Inc., 2929 Walker Ave NW, Grand Rapids, MI 49544, UPC: 0 41250 82918 8; l) Publix, Distributed by Publix Super Markets, Inc., 3300 Publix Corporate Parkway, Lakeland, FL 33811, UPC: 0 41415 01176 2; m) QUALITY CHOICE, Distributed by Quality Choice, Novi, MI 48376, UPC: 6 35515 99505 5; n) REDNESS RELIEF ASTRINGENT, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, UPC: 0 50428 79686 3; o)Rexall, Manufactured for: Rexall Brands Corp., Mississauga, Ontario L4Z 1R9, Imported by: Arrow OTC Company, Mississauga, Ontario L5N 2B8, UPC: 7 71058 10159 8; p) Rexall, Fabrique pour: Rexall Brands Corp., Mississauga, Ontario L4Z 1R9, Importe par: Arrow OTC Company, Mississauga, Ontario L5N 2B8, UPC: 7 71058 10159 8; q) select brand, Distributed by: SELECT BRAND DISTRIBUTORS, Pine Bluff, AR 71603, UPC: 0 15127 00363 6; r) Smart sense, Distributed by: Kmart Corporation, Hoffman Estates, IL 60179, UPC: 7 20007 96092 2; s) TopCare, Distributed by Topco Associates LLC, 7711 Gross Point Road, Skokie, IL 60077, UPC: 0 36800 03640 6; t)WESTERN FAMILY, Distributed by Western Family Foods, Inc., P.O. Box 4057 Portland, OR 97208, UPC: 0 15400 04552 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 →
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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