Class II · Moderate risk Terminated
PHENYLephrine HCl, 40 mg per 250 mL, (160 mcg per mL) in 0.9% Sodium Chloride Injection, Rx Only, SterRx, 141 Idaho Ave…
Reason Lack of Assurance of Sterility
Is Phenylephrine recalled?
292 FDA recalls mention Phenylephrine. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Phenylephrine.
Class II · Moderate risk Terminated
Phenylephrine HCl Injection, USP, 10 mg per mL, 1 mL per Single-Dose Vial packaged in 25 x 1 mL Single-Dose Vials per carton, For…
Reason Lack of Assurance of Sterility: customer complaints of loose crimped vial overseals which may result in a non-sterile product.
Class II · Moderate risk Terminated
PHENYLephrine HCl 5000 mg/50 mL in Sodium Chloride 0.9% (100 mcg/mL) Rx Only, 5 mL Single Dose Syringe, SCA Pharmaceuticals, 755…
Reason Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Class II · Moderate risk Terminated
PHENYLephrine HCl 500 mcg/5mL in 0.9% Sodium Chloride (100 mcg/mL), Rx Only, 5 mL Single Dose Syringe, SCA Pharmaceuticals, 755…
Reason Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Class II · Moderate risk Terminated
PHENYLephrine HCl 800 mcg/10 mL in 0.9% Sodium Chloride (80 mcg/mL), Rx Only, 10 mL Single Dose Syringe, SCA Pharmaceuticals…
Reason Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Class II · Moderate risk Terminated
PHENYLephrine HCl 1000 mcg/10 mL in 0.9% Sodium Chloride, (100 mcg/mL) Rx Only, 10 mL Single Dose Syringe, SCA Pharmaceuticals…
Reason Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Class II · Moderate risk Terminated
Ibuprofen 200 mg Chlorpheniramine Maleate 4mg Phenylephrine 10 mg tablets. Advil Allergy & Congestion Relief 10 and 20 count…
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
Phenylephrine Hydrochloride Ophthalmic Solution, USP, 2.5%, 15 mL bottle, Rx only, Mfd. by: Akorn, Inc., Lake Forest, IL 60045…
Reason Lack of Assurance of Sterility: Out of specification results for container closure test which cannot guarantee the sterility of the product.
Class II · Moderate risk Terminated
Cyclopentolate HCl 1% (10 mg/mL) / Phenylephrine HCl 10% (100 mg/mL) / Tropicamide 1% (10 mg/mL) / Ketorolac Tromethamine 0.5% (5…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Cyclopentolate HCl 1% (5 mg/0.5 mL) / Phenylephrine HCl 2.5% (12.5 mg/0.5 mL) / Tropicamide 1% (5 mg/0.5 mL), 0.5 mL Fill in a 3…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Cyclopentolate HCl 1% (10 mg/mL) / Phenylephrine HCl 2.5% (25 mg/mL) / Tropicamide 1% (10 mg/mL) / Ketorolac Tromethamine 0.5% (5…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Cyclopentolate HCl 1% (10 mg/mL) / Phenylephrine HCl 2.5% (25 mg/mL) / Tropicamide 1% (10 mg/mL), Sterile Ophthalmic Topical…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Cyclopentolate HCl 1% (5 mg/0.5 mL) / Phenylephrine HCl 2.5% (12.5 mg/0.5 mL) / Tropicamide 1% (5 mg/0.5 mL) / Ketorolac…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
PHENYLephrine HCl in 0.9% Sodium Chloride (PF), 1 mg / 10 mL (0.1 mg/mL), 10 mL Fill in a 12 mL Single Dose Syringe Injection, Rx…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
PHENYLephrine HCl 1.5% (15 mg/mL) LIDOcaine 1% (10 mg/mL) (PF) (Sulfite Free) Ophthalmic Injection, 3 mL fill in a 5 mL Single…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Phenylephrine HCl 1.5% (15 mg/mL) Lidocaine HCl 1% (10 mg/mL) (PF) (Sulfite Free) Ophthalmic Injection, 3 mL Single Dose Syringe…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
S-LIDOCAINE HCL 1% / PHENYLEPHRINE1.5% (PF) INJ SOLN, 1ml syringe, Red Mountain Compounding Rx
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
NEOGEN-D (Dextromethorphan HBr, 30 mg; Guaifenesin, 200 mg; Phenylephrine HCl, 7.5 mg) in each 5 mL tsp, Raspberry Flavor, 16 fl…
Reason CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good…
Class II · Moderate risk Terminated
TUSSLIN (Dextromethorphan HBr, 28 mg; Guaifenesin, 388 mg; Phenylephrine HCl, 10 mg) in each 5 mL tsp, Grape Flavor, 16 Fl.oz…
Reason CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good…
Class II · Moderate risk Terminated
GENCONTUSS (Chlorpheniramine Maleate, 2mg; Dextromethorphan HBr, 10 mg; Phenylephrine HCl, 5 mg) in each 5 mL tsp, Cherry Flavor…
Reason CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good…
Class II · Moderate risk Terminated
PHENYLEPHRINE HCL 100 MCG/ML IN NACL 0.9% SYR, 10 ML per syringe, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Phenylephrine HCL PF INJ in 0.9% Sodium Chloride, 1000mcg/10mL (100mgc/mL), *Contains Sulfites*, 10mL Single-Dose Syringe, Rx…
Reason Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific…
Class II · Moderate risk Terminated
Lidocaine 0.5%/Phenylephrine 0.75% P.F. INJ, 1mL Sterile SDV, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee…
Reason Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific…
Class II · Moderate risk Terminated
Anu-Med brand of Hemorrhoidal Suppositories (Phenylephrine HCl 0.25%; Hard Fat 88.7%), 12 suppositories per carton, NDC…
Reason cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Class II · Moderate risk Terminated
Hemorrhoidal Suppositories (Phenylephrine HCl 0.25%; Hard Fat 88.7%), 12 Rectal Suppositories per carton, NDC: 0536-1389-12…
Reason cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
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