Class II · Moderate risk Terminated
Chlorpheniramine Maleate 4 mg tablets
Reason Superpotent Drug: Stability failure for assay at 6 months test time-point.
Is Pheniramine recalled?
Yes — there is an active recall. 1 ongoing FDA recall mention Pheniramine (40 total). Check the affected lots below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Pheniramine. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed.
Class II · Moderate risk Ongoing
Broncochem Cold & Tea
Reason Stability testing failures for one or two of the four active pharmaceutical ingredients among the finished drug products, i.e., Phenylephrine HCL, and/or Chlorpheniramine Maleate.
Class II · Moderate risk Terminated
Chlorpheniramine/Hyoscyamine
Reason Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Class II · Moderate risk Terminated
Naphcon A eye drops
Reason CGMP Deviations: products were stored outside the drug label specifications.
Class II · Moderate risk Terminated
Dologen 325 Caplet
Reason CGMP Deviations
Class II · Moderate risk Terminated
Dologen
Reason cGMP deviations
Class II · Moderate risk Terminated
Brompheniramine Maleate
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk Terminated
Brompheniramine Maleate
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk Terminated
Ibuprofen 200 mg Chlorpheniramine Maleate 4mg Phenylephrine 10 mg…
Reason Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.
Class II · Moderate risk Terminated
Hydrocodone Polistirex and Chlorpheniramine Polistirex…
Reason Superpotent Drug and Failed Stability Specifications: High out-of-specification results for the active ingredients, hydrocodone and chlorpheniramine, as well as high out-of-specification results for the preservatives.
Class II · Moderate risk Terminated
Gencontuss
Reason CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
Class II · Moderate risk Terminated
Kid Kare Childrens Cough/Cold Liquid
Reason cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Class II · Moderate risk Terminated
Pedia Relief Cough-Cold Oral Solution
Reason cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Class II · Moderate risk Terminated
Rugby Aller-chlor
Reason Microbial Contamination of Non Sterile Product; presence of yeast and potential B. cepacia contamination
Class II · Moderate risk Terminated
Rugby Aller-chlor
Reason Microbial contamination of Non-sterile Products; presence of yeast and potential B. cepacia contamination
Class II · Moderate risk Terminated
Aller-Chlor
Reason CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.
Class II · Moderate risk Terminated
Chlorpheniramine Maleate 10 mg/ml
Reason Lack of Assurance of Sterility
Class III · Low risk Terminated
Lodrane D
Reason 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 Terminated
Brompheniramine Maleate
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 impact on sterility assurance.
Class II · Moderate risk Terminated
Brompheniramine Maleate 20 mg/ml Injectable
Reason Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Class II · Moderate risk Terminated
Pheniramine Maleate active pharmaceutical ingredient packaged in…
Reason Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Class II · Moderate risk Terminated
Dexchlorpheniramine Maleate active pharmaceutical ingredient…
Reason Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Class II · Moderate risk Terminated
Peng/proc/strep/chlor/hyos
Reason Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.
Class III · Low risk Terminated
Poly-Tussin Ac Liquid
Reason Does Not Meet Monograph: Phenylephrine and pseudoephedrine are below monograph specifications, and label inaccurately contains wording "Rx Only".
Class II · Moderate risk Terminated
Theraflu Cold and Flu
Reason Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.
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