FDA Drug Recalls

P/P/P 0.02/40/2mg/mL(Prostaglandin//Papaverine/Phentolamine) Injection, 0.02/40/2 mg/mL, 1 mL vial, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644.

Ranier's Compounding Laboratory

Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.

Avastin 1.25 mg/0.05 mL prefilled syringe, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644.

Ranier's Compounding Laboratory

Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.

Class IITerminated

PRASH 12.2mcg/1.22m/19.29 (Prostaglandin/Phentolamine/Papaverine) Injection, 10 mL vial, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644.

Ranier's Compounding Laboratory

Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.

July 25, 2018 · DrugView details →

Acetylcysteine 10% Oph Solution, 10 mL droptainer, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644.

Ranier's Compounding Laboratory

Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.

Dymista (azelastine hydrochloride and fluticasone propionate) Nasal Spray, 137 mcg / 50 mcg per spray, packaged in a 23 g net fill weight, Rx only, Manufactured by: Cipla Ltd., Goa, India, M.L.,, NDC 0037-0245-23

Mylan Pharmaceuticals Inc.

Presence of foreign substance: Potential for glass in the neck area of the glass bottles.

Papav 300/Phent 5mg/10mL (Papaverine/Phentolamine) Injection,300 mg/5 mg/10 mL, 10 mL vial, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644.

Ranier's Compounding Laboratory

Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.

Vitamin D3 Injection, 50,000 IU/mL, 4 mL vial, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644.

Ranier's Compounding Laboratory

Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.

PR/PA/PH (Prostaglandin/Papaverine/Phentolamine) Injection, 10mcg/30/1mg/mL, 10 mL vial, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644.

Ranier's Compounding Laboratory

Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.

alba BOTANICA Sensitive Sheer Shield Sunscreen Fragrance Free spf 50+ , 85 g 3 oz tube. Manufactured by: The Haine Celestial Group, Inc. Lake Success, NY, UPC 7 24742 00438 5

The Hain Celestial Group, Inc. - Worldwide HQ

Microbial Contamination of a Non-Sterile Product

Morphine Sulf inhalation, 5mg/3cc, 3cc per vial, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644.

Ranier's Compounding Laboratory

Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.

Dehydrated Alcohol Solution, packaged in a) 1 mL and b) 3 mL vials, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644.

Ranier's Compounding Laboratory

Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.

DMSO 6.25% Opth Sol, 10 mL droptainer, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644.

Ranier's Compounding Laboratory

Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.

Medroxprogesterone 1% Ophthalmic Solution, 10 mL droptainer, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644.

Ranier's Compounding Laboratory

Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.

PRO/PA/PH/AT 18mcg/1.8mg/ (Prostaglandin//Papaverine/Phentolamine/Atropine) Injection, 18mcg/1.8 mg/0.2 mg/0.02 mg/mL, 10 mL vial, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644.

Ranier's Compounding Laboratory

Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.

Atropine 0.01% Opth Solution, 5 mL droptainer, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644.

Ranier's Compounding Laboratory

Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.

Prednisolone Sodium Phosphate Oral Solution, 15 mg/5 mL, 8 fl oz (237 mL) Bottle, Rx only, Manufactured By: Morton Grove Pharmaceuticals, Inc., Morton Grove, IL 60053, NDC 60432-212-08.

Morton Grove Pharmaceuticals, Inc.

Defective Container: Tamper Evident foil seal not completely intact.

Doxycycline Hyclate Tablets, USP, 100 mg*. 500-count bottle, Rx only. Manufactured by: West-Ward Pharmaceuticals Corp. Eatontown, NJ 07724. NDC# 0143-2112-05.

West-Ward Columbus Inc

Failed Dissolution Specifications:

Doxycycline Hyclate Tablets, USP, 100 mg*. 50-count bottle, Rx only. Manufactured by: West-Ward Pharmaceuticals Corp. Eatontown, NJ 07724. NDC# 0143-2112-50.

West-Ward Columbus Inc

Failed Dissolution Specifications:

10 mg/mL Rocuronium Bromide (Preservative Free) 5 mL BD Syringe, PharMEDium Services, LLC.

PharMEDium Services, LLC

CGMP deviations: Product was released while a hood certification discrepancy was being investigated.

5 mg/mL Ephedrine Sulfate (Preservative Free) in 0.9% Sodium Chloride 5 mL in 5 mL BD Syringe Kit Check Tagged, PharMEDium Services, LLC.

PharMEDium Services, LLC

CGMP deviations: Product was released while a hood certification discrepancy was being investigated.