Class II · Moderate risk Terminated
Dologen 325 Caplet (Acetaminophen 325 mg, Dexbrompheniramine Maleate 1.0 mg) Bulk Container, ULTRAtab Laboratories, Inc…
Reason CGMP Deviations
Is Brompheniramine recalled?
10 FDA recalls mention Brompheniramine. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Brompheniramine.
Class II · Moderate risk Terminated
Dologen (acetaminophen 325 mg and dexbrompheniramine maleate 1mg) caplets, packaged in a) 90-count bottles, b) 2-count packets…
Reason cGMP deviations
Class II · Moderate risk Terminated
Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide Oral Syrup Net: 1 Pint (473 mL) Bulk…
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk Terminated
BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE SYRUP 10-30-2MG/5ML 473ML; NDC/UPC…
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class III · Low risk Terminated
Lodrane D (Brompheniramine maleate 4 mg and Pseudoephedrine HCl 60 mg) Capsules, 60-count bottles, Distributed by: Valeant…
Reason Labeling: Not Elsewhere Classified: correctly labeled bottles were packaged in cartons that were mislabeled with an incorrect active ingredient…
Class II · Moderate risk Terminated
Brompheniramine Maleate (10 mg/mL), 10 mL Multi-Dose Vial, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas…
Reason Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an…
Class II · Moderate risk Terminated
Brompheniramine Maleate 20 mg/ml Injectable, Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN
Reason Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Class III · Low risk Terminated
POLY-TUSSIN AC LIQUID, Each 5 mL (1 teaspoonful) contains: Brompheniramine Maleate 4 mg, Codeine Phosphate 10 mg, Phenylephrine…
Reason Does Not Meet Monograph: Phenylephrine and pseudoephedrine are below monograph specifications, and label inaccurately contains wording "Rx Only".
Class II · Moderate risk Terminated
Brompheniramine 10ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
Reason The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free…
Class II · Moderate risk Terminated
BROMPHENIRAMINE/PSEUDOEPHEDRINE DM, LIQUID, Antihistamine, Cough Suppressant, Decongestant, 16 fl oz. bottle, OTC…
Reason CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
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