Reason: Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can re...
Reason: Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can re...
D-1425-2019July 3, 2019Weeki Wachee, FL
Premier Pharmacy Labs Inc
Class IITerminated
Brilliant Blue Ophthalmic PF INJ, 0.5mg/mL (0.05%), 1 mL SDV, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-211-31, barcode 2 69623 21131 0.
Reason: Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can re...
D-1412-2019July 3, 2019Weeki Wachee, FL
Premier Pharmacy Labs Inc
Class IITerminated
Isoproterenol HCL in D5W (Non Sterile to Sterile), 200mcg/50mL (4mcg/mL), 50mL Sterile Single-Dose Bag, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-240-57, ...
Reason: Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can re...
D-1417-2019July 3, 2019Weeki Wachee, FL
American Health Packaging
Class IITerminated
Pramipexole Dihydrochloride Tablets, 0.125 mg, 30 Tablets (6 tablets per blister card), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217 NDC Blister Card: 68084-793-95; NDC ...
Reason: GMP Deviations; possible cross contamination of product due to cleaning procedure failure.
Reason: Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can re...
D-1428-2019July 3, 2019Weeki Wachee, FL
Premier Pharmacy Labs Inc
Class IITerminated
Droperidol Injectable Sterile Solution, 0.625mg/mL, 1mL in a 3mL Sterile Single-Use Syringe, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-185-10, barcode 0 6...
Reason: Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can re...
Reason: Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can re...
Reason: cGMP Deviations: Firm was notified by their supplier of Cetirizine HCL Oral Solution, USP, 1mg/mL, 4oz, of the voluntary recall that they have initiated due to potential contaminat...
D-1409-2019June 26, 2019Westbury, NY
Zydus Pharmaceuticals USA Inc
Class IITerminated
Pramipexole Dihydrochloride Tablets 0.5 mg, 90-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534. NDC ...
Reason: CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Reason: cGMP Deviations: Firm was notified by their supplier of Cetirizine HCL Oral Solution, USP, 1mg/mL, 4oz, of the voluntary recall that they have initiated due to potential contaminat...
D-1407-2019June 26, 2019Westbury, NY
Zydus Pharmaceuticals USA Inc
Class IITerminated
Pramipexole Dihydrochloride Tablets 1 mg, 90-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534. NDC 683...
Reason: CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Reason: CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
D-1448-2019June 26, 2019Pennington, NJ
P & L Developments, LLC
Class IITerminated
Cetirizine Oral Solution 1 mg/mL, Children's Allergy, Antihistamine, Dye Free, Grape Flavor, 4 FL. oz. Bottle, Distributed by C.D.M.A. Inc., Novi, MI 48376, Quality Choice, NDC 63868-430-04, UPC 63551...
Reason: cGMP Deviations: Firm was notified by their supplier of Cetirizine HCL Oral Solution, USP, 1mg/mL, 4oz, of the voluntary recall that they have initiated due to potential contaminat...
D-1408-2019June 26, 2019Westbury, NY
Zydus Pharmaceuticals USA Inc
Class IITerminated
Pramipexole DihydrochlorideTablets 0.125 mg, 90-count bottle, Rx Only, Manufactured by: Cadila Healthcare Ltd Ahmedabad, India. Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534. NDC...
Reason: CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
D-1443-2019June 26, 2019Pennington, NJ
Zydus Pharmaceuticals USA Inc
Class IITerminated
Pramipexole Dihydrochloride Tablets 0.125 mg, 1,000-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534....
Reason: CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
D-1442-2019June 26, 2019Pennington, NJ
Zydus Pharmaceuticals USA Inc
Class IITerminated
Pramipexole Dihydrochoride Tablets 0.25 mg, 90-count bottle, Rx Only, Manufactured by: Cadila Healthcare Ltd Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534. NDC 6...
Reason: CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
D-1444-2019June 26, 2019Pennington, NJ
Preferred Pharmaceuticals, Inc
Class IITerminated
Robafen DM, Generic for Robitussin DM, In each teaspoonful (5mL): Dextromethorphan HBr, USP 10mg,/Guaifenesin, USP 100mg, 118mL (4oz) bottle, Manufactured for Preferred Pharmaceuticals, Inc., Anaheim,...
Reason: CGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
D-1410-2019June 26, 2019Anaheim, CA
American Health Packaging
Class IITerminated
Anastrozole Tablets, USP, 1mg, 30-count unit dose blisters per carton, Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC 60687-112-21.
Reason: GMP Deviations: Potential cross contamination due to cleaning procedure failure.