Class II · Moderate risk
Brompheniramine Maleate
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Brompheniramine Maleate
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
Cause type: Sterility / contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.
What was recalled
Brompheniramine Maleate (10 mg/mL), 10 mL Multi-Dose Vial, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3019-07
Affected NDC
62295-3019-07
Compare with the code on your package — it is the most precise check available.
Drug: Brompheniramine
- Recalling firm
- US Compounding Inc
- NDC code
- 62295-3019-07
- Origin
- AR, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0243-2016 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Brompheniramine recalls
See all
Class II · Moderate risk
Brompheniramine Maleate
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class III · Low risk
Lodrane D (Brompheniramine maleate 4 mg and Pseudoephedrine HCl 60 mg)
Labeling: Not Elsewhere Classified: correctly labeled bottles were packaged in cartons that were mislabeled with an incorrect active ingredient, phenylephrine rather than pseudoephedrine, on the carton face and carton top.
Class II · Moderate risk
Brompheniramine Maleate 20 mg/ml Injectable
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Class III · Low risk
Poly-Tussin Ac Liquid
Does Not Meet Monograph: Phenylephrine and pseudoephedrine are below monograph specifications, and label inaccurately contains wording "Rx Only".
Other recalls by US Compounding Inc
All 2015 recalls
Class III · Low risk
Succinylcholine Chloride PF Inj. 200 mg/10 mL
Labeling: Incorrect or Missing lot and/or expiration date: The lot number and BUD were printed in the incorrect position on the product label making it illegible.
Class III · Low risk
Neostigmine Methylsulfate PF Inj. 5 mg/5 mL
Labelling: Missing label.
Class II · Moderate risk
Ephedrine Sulfate
Lack of assurance of sterility.
Class II · Moderate risk
LET Gel 4%
Labeling: Incorrect or Missing Lot and/or Exp Date: Labels are missing lot and expiration date and are printed as Lot# YYYDDYY@XX with a Beyond Use Date: MM/DD/YYY.
Free recall alerts
Know the day your medication is recalled
Tell us what you take. When FDA posts a recall announcement or classifies a recall for one of your medications, we email you in plain English, with what to check. No account needed.