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
Presence of Particulate Matter
Prescription and over-the-counter medications
B BRAUN MEDICAL
Presence of Particulate Matter
Subpotent Drug
Boothwyn Pharmacy
Subpotent Drug
MEDLINE INDUSTRIES, LP - Northfield
Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
MEDLINE INDUSTRIES, LP - Northfield
Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
Correct Labeled Product Mispack: Bags labeled for Enoxaparin Sodium Injection, 80 mg/0.8 mL, contained Enoxaparin Sodium Injection, 30 mg/0.3 mL
MEDLINE INDUSTRIES, LP - Northfield
Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
Discoloration
MEDLINE INDUSTRIES, LP - Northfield
Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
Labeling: Label Mix-up. A bottle labeled as Lisdexamphetamine Dimesylate Capsules 40mg, contained Lisdexamphetamine Dimesylate Capsules 30mg.
Amerisource Health Services
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.
MEDLINE INDUSTRIES, LP - Northfield
Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
MEDLINE INDUSTRIES, LP - Northfield
Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
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
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.
Lack of Assurance of Sterility.
Lack of Assurance of Sterility.
Discoloration
The Harvard Drug Group LLC
CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm
Taizhou Kangping Medical Science And Technology Co.
Lack of Assurance of Sterility.