FDA Recall
Terminated
Historical recordClass II
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 69623 18510 5.
by Premier Pharmacy Labs Inc
- Reason
- Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance.
- Published
- July 3, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
ChlorproMAZINE HCL INJ, 25mg/mL, *Contains Sulfites*, 1mL in a 5mL Sterile SDV, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-122-28, barcode 7 69623 12228 4.
by Premier Pharmacy Labs Inc
- Reason
- Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance.
- Published
- July 3, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
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.
by Premier Pharmacy Labs Inc
- Reason
- Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance.
- Published
- July 3, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Atropine Sulfate PF INJ, 0.8 mg/2 mL (0.4 mg/mL), 2mL Single Dose Syringe, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-131-12, barcode 0 69623 13112 6.
by Premier Pharmacy Labs Inc
- Reason
- Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance.
- Published
- July 3, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
MethylPREDNISolone Tablets, USP 8 mg, 25 tablets, Rx Only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India NDC 68382-917-11
by Zydus Pharmaceuticals USA Inc
- Reason
- CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
- Published
- June 26, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Pramipexole Dihydrochloride Tablets 1.5 mg 90-count bottle, Rx only Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ NDC 68382-200-16
by Zydus Pharmaceuticals USA Inc
- Reason
- CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
- Published
- June 26, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
MethylPREDNISolone Tablets, USP 32 mg, 25 tablets, Rx Only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India NDC 68382-919-11
by Zydus Pharmaceuticals USA Inc
- Reason
- CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
- Published
- June 26, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
MethylPREDNISolone Tablets, USP 16 mg, 50 tablets, Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India NDC 68382-918-18
by Zydus Pharmaceuticals USA Inc
- Reason
- CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
- Published
- June 26, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
MethylPREDNISolone Tablets, USP 4 mg per tablet, 21 Tablets dosepack, Rx Only, Made in India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534. NDC 68382-916-34
by Zydus Pharmaceuticals USA Inc
- Reason
- CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
- Published
- June 26, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
MethylPREDNISolone Tablets, USP, 4 mg, 100 tablets, Rx only, Manufactured by: Cadila Healthcare Ltd Ahmedabad, India NDC 68382-916-01
by Zydus Pharmaceuticals USA Inc
- Reason
- CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
- Published
- June 26, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
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 68382-199-16
by Zydus Pharmaceuticals USA Inc
- Reason
- CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
- Published
- June 26, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
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 68382-198-16
by Zydus Pharmaceuticals USA Inc
- Reason
- CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
- Published
- June 26, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Pramipexole Dihydrochloride Tablets 0.25 mg, 1000-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India. NDC 68382-197-10
by Zydus Pharmaceuticals USA Inc
- Reason
- CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
- Published
- June 26, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
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 68382-197-16
by Zydus Pharmaceuticals USA Inc
- Reason
- CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
- Published
- June 26, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
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 68382-196-16
by Zydus Pharmaceuticals USA Inc
- Reason
- CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
- Published
- June 26, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
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. NDC 68382-196-10
by Zydus Pharmaceuticals USA Inc
- Reason
- CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
- Published
- June 26, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Anastrozole Tablets, USP, 1 mg, 1,000-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals (USA) Inc. Pennington, NJ 08534. NDC 68382-209-10
by Zydus Pharmaceuticals USA Inc
- Reason
- CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
- Published
- June 26, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
ANASTROZOLE Tablets, 1 mg, Rx Only, 30-count bottle, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India. Distributed by: Zydus Pharmaceuticals (USA) Inc. Pennington, NJ 08534 NDC 68382-209-06
by Zydus Pharmaceuticals USA Inc
- Reason
- CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
- Published
- June 26, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Cetirizine Oral Solution 1 mg/mL, Up & Up, Children's allergy relief, Antihistamine, Dye Free, Grape Flavor, 4 FL. oz. (118 mL) Bottle, Distributed by Target Corporation, Minneapolis, MN 55403, NDC 11673-178-04, UPC 359726178044.
by P & L Developments, LLC
- 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 contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
- Published
- June 26, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
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 635515992474.
by P & L Developments, LLC
- 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 contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
- Published
- June 26, 2019
- Distribution
- Nationwide
View recall →
Recall records are summarized from official FDA and USDA sources. Notices may be updated, reclassified, terminated, or withdrawn. Always review the linked official notice for the most current instructions.
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