FDA Recall
TerminatedTerminated: October 7, 2014Historical recordClass I
Lidocaine HCl Injection, USP, 2%, 20 mg per mL, packaged in 5-mL single-dose vials, 10 vials per box, Rx Only, Hospira, Inc., Lake Forest, IL. 60045, NDC 0409-2066-05.
by Hospira Inc.
- Reason
- Presence of Particulate Matter- Confimed customer complaint of particulates embedded in glass container and in contact with product solution.
- Published
- May 7, 2014
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: May 3, 2017Historical recordClass I
Adipotrim XT, New Powerful Formula, 30 rapid release capsules per bottle, Dietary Supplement, www.adipotrim.com.
by Deseo Rebajar
- Reason
- Marketed Without an Approved NDA/ANDA: FDA lab results found undeclared API Fluoxetine in this dietary supplement.
- Published
- May 7, 2014
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: July 22, 2015Historical recordClass I
Dianeal PD-2 Peritoneal Dialysis Solution with 1.5% Dextrose, 6000 mL Ambu-Flex II container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, Product Code L5B9710, NDC 0941-0411-11
by Baxter Healthcare Corp.
- Reason
- Non-Sterility: Complaints of leaks and particulate matter identified as mold in the solution bag and the overpouch.
- Published
- May 7, 2014
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: December 4, 2014Historical recordClass I
Hyperlyte CR (Multi-Electrolyte Concentrate), 20 mL/dose, 250 mL Container, Catalog No. S9432, Rx Only, Sterile, B Braun Medical Inc., Irvine CA 92614-5895, In Canada Dist by: B Braun Medical Inc., Scarborough, Ontario M1H 2W4, NDC 0264-1943-20, Canada DIN 01924311
by B. Braun Medical Inc
- Reason
- Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units.
- Published
- May 7, 2014
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: December 4, 2014Historical recordClass I
ProcalAmine (3% Amino Acid and 3% Glycerin Injection with Electrolytes) 1000 mL Container, Rx Only, Catalog No. S9050, Sterile, Single Dose Container, B Braun Medical Inc., Irvine CA 92614-5895, NDC 0264-1915-07
by B. Braun Medical Inc
- Reason
- Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units.
- Published
- May 7, 2014
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: December 4, 2014Historical recordClass I
TrophAmine (10% Amino Acid Injection), 500 mL Container, Rx Only, Catalog No. S9341-SS, Sterile, Single Dose Container, B Braun Medical Inc., Irvine CA 92614-5895, NDC 0264-9341-55
by B. Braun Medical Inc
- Reason
- Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units.
- Published
- May 7, 2014
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: December 4, 2014Historical recordClass I
15% Amino Acids Injection PBP Glass, 1000 mL, Catalog No. S3200-SS, Pharmacy Bulk Package, Not For Direct Infusion, For Intravenous Use, Sterile, Single Dose Container, Rx Only, B Braun Medical Inc., Irvine, CA 92614-5895, NDC 0264-3200-55
by B. Braun Medical Inc
- Reason
- Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units.
- Published
- May 7, 2014
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: December 4, 2014Historical recordClass I
6.9% FreAmine HBC (Amino Acid Injection), partial fill container 750 mL in a 1000 mL container, Catalog No. S9350-58SS, Sterile, Single dose container, Rx Only, B Braun Medical Inc., Irvine, CA 92614-5895, NDC 0264-9350-55
by B. Braun Medical Inc
- Reason
- Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units.
- Published
- May 7, 2014
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: December 4, 2014Historical recordClass I
0.9 % Sodium Chloride Injection USP, 1000 mL, Catalog No. S4000-SS, Rx Only, Sterile, Single Dose Container, B Braun Medical Inc., Irvine, CA 92614-5895, NDC 0264-4000-55
by B. Braun Medical Inc
- Reason
- Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units.
- Published
- May 7, 2014
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: December 4, 2014Historical recordClass I
Cefazolin for Injection USP and Dextrose Injection USP, 2 g in Duplex, 50 mL Container, Catalog Number 3105-11, Rx Only, B Braun Medical Inc., Irvine CA 92614, NDC 0264-3105-11
by B. Braun Medical Inc
- Reason
- Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units.
- Published
- May 7, 2014
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: December 4, 2014Historical recordClass I
Cefazolin for Injection USP and Dextrose Injections USP, 1 g in Duplex, 50 mL Container, Catalog Number 3103-11, For IV Use Only, Sterile, Single Dose, Rx Only, B Braun Medical Inc., Irvine CA 92614-5895, NDC 0264-3103-11
by B. Braun Medical Inc
- Reason
- Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units.
- Published
- May 7, 2014
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: December 4, 2014Historical recordClass I
Cefepime for Injections USP and Dextrose Injection USP, 1 g in Duplex, 50 mL Container, Catalog Number 3193-11, For IV Use Only, Single Dose, Sterile, Rx Only, B Braun Medical Inc., Irvine CA 92614-5895, NDC 0264-3193-11
by B. Braun Medical Inc
- Reason
- Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units.
- Published
- May 7, 2014
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: December 4, 2014Historical recordClass I
Ceftriaxone for Injection and Dextrose Injection, 1 g in Duplex, 50 mL Container, Catalog Number 3153-11, For IV Use Only, Single Dose, Sterile, Rx Only, B Braun Medical Inc., Irvine CA 92614-5895
by B. Braun Medical Inc
- Reason
- Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units.
- Published
- May 7, 2014
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: December 4, 2014Historical recordClass I
0.9 % Sodium Chloride Injection USP in PAB 50 mL partial fill in 100 mL PAB Container, Catalog No. S8004-5384, Rx Only, B Braun Medical Inc., Irvine CA 92614-5895, NDC 0264-1800-31
by B. Braun Medical Inc
- Reason
- Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units.
- Published
- May 7, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: December 4, 2014Historical recordClass I
Cefoxitin for Injection and Dextrose Injection, 1 g in Duplex, 50 mL Container, Catalog No. 3123-11, For IV Use Only, Single Use, Sterile, Rx Only, B Braun Medical Inc, Irvine CA 92614-5895, NDC 0264-3123-11
by B. Braun Medical Inc
- Reason
- Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units.
- Published
- May 7, 2014
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: November 16, 2016Historical recordClass I
Human Chorionic Gonadotropin, EP (HCG) in 5 mu. 2 mu, and 1 mu packages, For use and distribution in prescription compounding, manufacturing, processing or repacking only in accordance with FDA regulations and applicable law. Potency 5489.6IU/mg. Packed by Medisca, Inc. Irving, TX, 75063, USA NDC 38779-2673-1, NDC 38779-2673-2, and NDC 38779-2673-6. Lot Numbers 101751/A, Exp: 05/16, CAS: 9002-61-3; 101752/A, Exp: 05/16, CAS 9002-61-3; and 101799/A, Exp: 05/16, CAS: 9002-61-3
by Medisca Inc.
- Reason
- Labeling: Label Error on Declared Strength; Firm states that erroneous potency information was found on the label.
- Published
- May 7, 2014
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: December 15, 2014Historical recordClass II
Sevoflurane, USP (Inhalation Anesthetic), Rx Only, 250 mL Amber Bottle. Manufactured By: Piramal Critical Care, 3950 Schelden Circle, Bethlehem, PA 18017. NDC: 66794-015-25.
by Piramal Critical Care, Inc.
- Reason
- Failed pH Specifications: product was too acidic.
- Published
- May 7, 2014
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: June 30, 2015Historical recordClass II
Potassium Chloride for Inj. Concentrate, USP, 40 mEq (2 mEq/mL), 20 mL Single-dose Fliptop Vial, For IV use, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA
by Hospira Inc.
- Reason
- Presence of Particulate; red and black particulate within the solution and embedded within the plastic vial identified as iron oxide
- Published
- April 30, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: May 1, 2015Historical recordClass II
Non-Drowsy 24 Hour Formula Allergy Relief and Nasal Decongestant, Pseudoephedrine Sulfate, USP 240 mg , Loratadine, USP, 10 mg, 5, 10, 15 count blister packs, OTC Only. Labeled A) CVS Allergy Relief - D, Pseudoephedrine, USP 240 mg/Nasal Decongestant Loratadine, USP 10 mg/Antihistamine Extended Release Tablets, 5-count box Distributed by CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02805 UPC 050428049631 B) Discount Drug Mart Non-Drowsy 24 Hour Formula Allergy Relief and Nasal Decongestant, Loratadine, USP 10 mg/Antihistamine Pseudephrine Sulfate, USP 240 mg/Nasal Decongestant Extended Release Tablets, 15-count box Distributed by Drug Mart-Food Fair Medina, Ohio 44256 UPC 093351116285 C) Kroger Non-Drowsy Allergy and Congestion Loratadine and Pseudoephedrine Extended Release Tablets Pseudoephedrine Sulfate, USP 240 mg Nasal Decongestant Loratadine, USP 10 mg, Antihistamine 10- count box, Distributed by The Kroger Co., Cincinnati, Ohio 45202 NDC 30142-0724-69. D) Sunmark Allergy & Congestion Lorata*dine D Pseudoephedrine Sulfate, USP 240 mg/Nasal Decongestant Loratadine, USP 10 mg/Antihistamine Extended Release Tablets, Indoor & Outdoor Allergies, Non-Drowsy 10- count box, Distributed by Mckesson One Post Street, San Francisco, CA 94104 NDC 49348-543-01 E) Good Neighbor Pharmacy Non-Drowsy Allergy and Congestion Relief pseudoephedrine sulfate, USP 240 mg/nasal decongestant loratadine, USP 10 mg/antihistamine Indoor & Outdoor Allergies Extended-Release Tablets, 10- count box, Distributed by Amerisource Bergen 1300 Morris Drive, Chesterbrook, PA 19087 NDC46122-0167-52 F) H-E-B Allergy Relief - D Non-Drowsy- 24 Hour Formula Loratadine, USP 10mg/Antihistamine Pseudoephedrine Sulfate, USP 240 mg/Nasal Decogestant Indoor & Outdoor Allegies, Allergy & Congestion Extended-Release Tablets 10-count box, Distributed by H-E-B San Antonio, TX 78204 NDC 37808-0724-69 G) Rite Aid Pharmacy allergy relief & nasal decongestant loratadine USP, 10 mg, pseudoephedribe sulfate USP, 240 mg, antihistamine & nasal degestant, extended release tablets, 10- count box, Distributed by: Rite Aid 30 Hunter Lane Camp Hill, PA 17011 UPC 0118223315555
by Ohm Laboratories, Inc.
- Reason
- Defective Container: An unacceptable level of blister defects have been identified in Loratadine and Pseudoephedrine Sulfate Extended Release Tablets, 10 mg/240 mg.
- Published
- April 30, 2014
- Distribution
- CA OH, PA, RI,& TX
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FDA Recall
TerminatedTerminated: July 1, 2014Historical recordClass III
Oxandrolone Tablets, USP, 10 mg, Rx Only, C-III, 60-count bottle, Manufactured for: Upsher-Smith Labs, Minneapolis, MN 55447, by: Pharmaceutics International, Inc., Hunt Valley, MD 21031, NDC 0245-0272-06
by Upsher Smith Laboratories, Inc.
- Reason
- Labeling: Missing Label; Three cases of product (total of 36 bottles) were packaged without the primary label on the bottle. The cases were, however, packaged in the correct finished product shipper, labeled with the correct shipper bar code label, sealed with tamper-evident tape and erroneously shipped to Upsher-Smith.
- Published
- April 30, 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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