Class II · Moderate risk Terminated
Theraflu Exte
Reason Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.
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 Terminated
NeoCitran DM Cough & Cold
Reason Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.
Class II · Moderate risk Terminated
NeoCitran Extra Strength Cold & Flu
Reason Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.
Class II · Moderate risk Terminated
NeoCitran
Reason Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.
Class II · Moderate risk Terminated
NeoCitran Extra Strength
Reason Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.
Class II · Moderate risk Terminated
Theraflu
Reason Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.
Class II · Moderate risk Terminated
Theraflu Flu & Sore Throat
Reason Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.
Class II · Moderate risk Terminated
Brompheniramine 10ml
Reason The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials.
Class III · Low risk Terminated
Theraflu Nighttime Warming Relief Nighttime Multi-Symptom Cold
Reason Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing.
Class III · Low risk Terminated
Maximum Strength Comtrex
Reason Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing.
Class III · Low risk Terminated
Maximum Strength Comtrex
Reason Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing.
Class III · Low risk Terminated
Maximum Strength Comtrex Nighttime Cold & Cough
Reason Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing.
Class III · Low risk Terminated
Maximum Strength Comtrex Day/Night Cold & Cough
Reason Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing.
Class II · Moderate risk Terminated
Pentrexcilina
Reason Labeling: Not Elsewhere Classified: Pentrexcilina Tablets and Pentrexcilina Liquid are being recalled because the product labels are misleading because they may be confused with Pentrexyl, a prescription antibiotic used to treat respiratory illnesses in Mexico.
Class II · Moderate risk Terminated
Brompheniramine/Pseudoephedrine Dm
Reason CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
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