Class I - Dangerous
Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia.
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Drugs Recalls
Prescription and over-the-counter medications
17,685 Total Recalls
Class I - Dangerous
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Semaglutide, 2.5 mg/mL injection, 2 mL., Boothwyn Pharmacy
Boothwyn Pharmacy
Class I - Dangerous
Subpotent Drug
Lactated Ringers's Injection USP, 1000 mL container, Rx only, B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0264-7750-07
B BRAUN MEDICAL
Class I - Dangerous
Presence of Particulate Matter
Subpotent Drug
Semaglutide, 2.5 mg/mL injection, 4 mL, Boothwyn Pharmacy
Boothwyn Pharmacy
Class I - Dangerous
Subpotent Drug
Good Neighbor Pharmacy, Alcohol Prep Pads, Distributed By AmeriSource Bergen, 1 West First Avenue, Conshohocken, PA 19428, Made in China: 100 eaches per box, 30 boxes per case, (3,000 eaches per case), NDC 46122-043-78.
MEDLINE INDUSTRIES, LP - Northfield
Class I - Dangerous
Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
CURAD Alcohol Prep Pads, Sterile, Medium, 2-Ply, Contents: 5 boxes per Carton, 30 Boxes per Case, Single Use Only, Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL 60093, USA, Made in India, www.curad.com, 1-800-633-5463, NDC 53329-827-30
MEDLINE INDUSTRIES, LP - Northfield
Class I - Dangerous
Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
Class I - Dangerous
Correct Labeled Product Mispack: Bags labeled for Enoxaparin Sodium Injection, 80 mg/0.8 mL, contained Enoxaparin Sodium Injection, 30 mg/0.3 mL
ReliOn, Sterile Alcohol Swabs, Skin Cleanser, 200 Swabs, Distributed by, Walmart, Inc., Bentonville, AR 72716 Walmart: 200 eaches per box, 24 boxes per case (4,800 eaches per case), NDC 49035-814-60.
MEDLINE INDUSTRIES, LP - Northfield
Class I - Dangerous
Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
Class I - Dangerous
Discoloration
Medline Alcohol Prep Pads, 70% Isopropyl Alcohol, 100 Sterile 2-Ply Pads, Single Use Only, Large, www.medline.com, Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL 60093 USA, 1-800-MEDLINE, NDC 53329-811-30.
MEDLINE INDUSTRIES, LP - Northfield
Class I - Dangerous
Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
Class I - Dangerous
Labeling: Label Mix-up. A bottle labeled as Lisdexamphetamine Dimesylate Capsules 40mg, contained Lisdexamphetamine Dimesylate Capsules 30mg.
Sucralfate Tablets, USP 1 gram, 100 Tablets, (10x10), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217 NDC 60687-695-01 - Carton NDC [60687-695-11- Unit Dose]
Amerisource Health Services
Class I - Dangerous
CGMP Deviations: The recalling firm filed for Chapter 11 in September 2024. As a result, it cannot monitor the quality program and hence cannot assure that products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess, rendering the products adulterated.
RITE AID PHARMACY, first aid alcohol prep pads, DISTRIBUTED BY: RITE AID. 200 NEWBERRY COMMONS, ETTERS, PA 17319, NDC 11822-5156-2.
MEDLINE INDUSTRIES, LP - Northfield
Class I - Dangerous
Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
H-E-B, inControl, Sterile* Alcohol Pads, CONT. 100 PADS, Packaged in China with components from Taiwan, Elaborado Con Orgullo Y Cuidado PARA H-E-B, San Antonio, TX 78204, NDC 37808-809-09.
MEDLINE INDUSTRIES, LP - Northfield
Class I - Dangerous
Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
Class I - Dangerous
Labeling: Label Mix-up: The outer carton is labelled Fresh Mint. The tube is labelled Cool Mint/Whitening. The toothpaste inside the tube is Fresh Mint as indicated on the outer carton
Class I - Dangerous
Failed Stability Specifications: Out of specification results was observed in Induction Port during the analysis of Particle size distribution at the 12-month time point.
Class I - Dangerous
Lack of Assurance of Sterility.
Class I - Dangerous
Lack of Assurance of Sterility.