Class II · Moderate risk Terminated
Phenylephrine HCl Injection, USP, 0.8 mg/10 mL (80 mcg/mL)syringe, packaged in 5 x 10 mL Pre-Filled Syringes per carton, 6 x 5…
Reason Lack of Assurance of Sterility
Is Phenylephrine recalled?
Yes — there is an active recall. 17 ongoing FDA recalls mention Phenylephrine (292 total). Check the affected lots below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Phenylephrine. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed.
Class II · Moderate risk Terminated
Phenylephrine HCl Injection, USP, 0.4 mg/10 mL (40 mcg/mL) syringe, packaged in 5 x 10 mL Pre-Filled Syringes per carton, 6 x 5…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Phenylephrine HCl Injection, USP, 1 mg/10 mL (100 mcg/mL), 10 mL Pre-Filled Syringe, 5 x 10 mL Pre-Filled Syringes, 6 x 5 Syringe…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Phenylephrine HCl Injection, USP, 0.8 mg/10 mL (80 mcg/mL), 10 mL Pre-Filled Syringes, 5 x 10 mL Pre-Filled Syringes, 6 x 5…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Phenylephrine HCl Injection, USP, 0.4 mg/10 mL (40 mcg/mL), 10 mL Pre-Filled Syringe, 5 x 10 mL Pre-Filled Syringes, 6 x 5…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Completed
Phenylephrine 1 mg/mL, Multi-Dose 5 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835. NDC…
Reason Lack of assurance of sterility.
Class II · Moderate risk Terminated
Phenylephrine 1 mg/mL, 5 mL Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC…
Reason CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly…
Class II · Moderate risk Terminated
Phenylephrine HCl Injection in 0.9% Sodium Chloride, 20 mg, 250 mL excel bag, Rx only, Athenex Pharma Solutions, LLC, Clarence…
Reason Defective container
Class II · Moderate risk Terminated
Phenylephrine HCl Injection 50 mg per 250 mL in 0.9% Sodium Chloride, 50 mg, 250 mL excel bag, Rx only, Athenex Pharma Solutions…
Reason Defective container
Class II · Moderate risk Terminated
Phenylephrine HCl Injection 40 mg per 250 mL in 0.9% Sodium Chloride, 40 mg, 250 mL excel bag, Rx only, Athenex Pharma Solutions…
Reason Defective container
Class II · Moderate risk Terminated
Coated Phenylephrine HCl 5mg Tablet (Phenylephrine HCl 5mg ) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC…
Reason CGMP Deviations
Class II · Moderate risk Terminated
Phenylephrine HCl 5 mg Tablet (Phenylephrine HCl 5mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-333-00
Reason CGMP Deviations
Class II · Moderate risk Terminated
APAP 500 mg Phenyl HCl 5mg tablet (Acetaminophen 500mg, Phenylephrine HCl 5mg), Bulk Container, ULTRAtab Laboratories, Inc…
Reason CGMP Deviations
Class II · Moderate risk Terminated
APAP 325 mg/Phenylephrine HCl, 5mg Tablets Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-135-00
Reason CGMP Deviations
Class II · Moderate risk Terminated
Coated APAP 325 mg Phenyl HCl 5 mg tablet (Acetaminophen 325 mg, Phenylephrine HCl 5mg) Bulk Container, ULTRAtab Laboratories…
Reason CGMP Deviations
Class II · Moderate risk Terminated
Kramer Novis Tusicof Caplet (Guaifenesin 400 mg, Dextromethorphan HBr 20 mg, Phenylephrine HCl 10 mg) Bulk Container, ULTRAtab…
Reason CGMP Deviations
Class II · Moderate risk Terminated
Zee Cold Tabs (Acetaminophen 325 mg, Guaifenesin 100 mg, Phenylephrine HCl 5 mg Bulk Container, ULTRAtab Laboratories, Inc…
Reason CGMP Deviations
Class II · Moderate risk Terminated
4-Component Cold Tabs (Acetaminophen 325 mg, Guaifenesin 200 mg, Dextromethorphan HBr 15mg, Phenylephrine HCL 5mg) Bulk…
Reason CGMP Deviations
Class II · Moderate risk Terminated
3-Component Cold Tabs (Acetaminophen 325 mg, Guaifenesin 200 mg, Phenylephrine HCl 5mg) Bulk Container, ULTRAtab Laboratories…
Reason CGMP Deviations
Class II · Moderate risk Terminated
Leader Nasal Decongestant PE (Phenylephrine HCl 10 mg), 18 Tablets per cartons, Distributed By Cardinal Health, Dublin, Ohio…
Reason CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class II · Moderate risk Terminated
Sinus Relief Headache/Nasal (acetaminophen 325mg, phenylephrine HCl 5mg), 2 tablet packets, Manufactured for Select Corporation…
Reason cGMP deviations
Class II · Moderate risk Terminated
Sinus Relief (acetaminophen 325mg, Guaifenesin 200mg, phenylephrine HCl 5mg), 2-tablet packets, Manufactured for Select…
Reason cGMP deviations
Class II · Moderate risk Terminated
SINUS DECONGESTANT Nasal Decongestant (phenylephrine HCl 5mg) tablets, 2-count packets, Dist. by Honeywell Safety Products USA…
Reason cGMP deviations
Class II · Moderate risk Terminated
CETAFEN COUGH & COLD COUGH & COLD RELIEF (Acetaminophen 325 mg, Dextromethorphan HBr 15mg, Guaifenesin 200mg, phenylephrine HCl…
Reason cGMP deviations
Class II · Moderate risk Terminated
Pain & Sinus Reliever Pain Reliever/Nasal Decongestant (acetaminophen 500mg, Phenylephrine HCl 5mg) 2 tablet packets, Mfg for…
Reason cGMP deviations
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