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FDA Recalls
›Drug Recalls

FDA Drug Recalls

Recalls of prescription drugs, over-the-counter medications, and compounded pharmaceuticals.

Classification

All Class I Class II Class III

Status

All Ongoing Completed Terminated

Date

All time Past 30 days Past 12 months

Showing 7601–7620 of 17,773 recalls

Class IITerminated

MethylPREDNISolone Tablets, USP, 4 mg, 100 tablets, Rx only, Manufactured by: Cadila Healthcare Ltd Ahmedabad, India NDC 68382-916-01

Zydus Pharmaceuticals USA Inc

CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.

May 6, 2019 · DrugView details →

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 68382-198-16

Zydus Pharmaceuticals USA Inc

CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.

May 6, 2019 · DrugView details →

Class IITerminated

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

Zydus Pharmaceuticals USA Inc

CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.

May 6, 2019 · DrugView details →

Class IITerminated

MethylPREDNISolone Tablets, USP 8 mg, 25 tablets, Rx Only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India NDC 68382-917-11

Zydus Pharmaceuticals USA Inc

CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.

May 6, 2019 · DrugView details →

Class IITerminated

MethylPREDNISolone Tablets, USP 16 mg, 50 tablets, Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India NDC 68382-918-18

Zydus Pharmaceuticals USA Inc

CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.

May 6, 2019 · DrugView details →

Class IITerminated

Senna (sennosides 8.8 mg) Syrup 8 fl oz. (236 mL) bottles, Distributed by Geritrex, LLC 40 Commercial Avenue Middletown, NY 10941, NDC 54162-007-08

Geritrex, LLC

Failed Impurities/Degradation Specifications: Atypical odor and unpleasant taste was reported

May 6, 2019 · DrugView details →

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 68382-197-16

Zydus Pharmaceuticals USA Inc

CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.

May 6, 2019 · DrugView details →

Class IITerminated

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

Zydus Pharmaceuticals USA Inc

CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.

May 6, 2019 · DrugView details →

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 68382-196-16

Zydus Pharmaceuticals USA Inc

CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.

May 6, 2019 · DrugView details →

Class IITerminated

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

Zydus Pharmaceuticals USA Inc

CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.

May 6, 2019 · DrugView details →

Class IITerminated

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

Zydus Pharmaceuticals USA Inc

CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.

May 6, 2019 · DrugView details →

Class IITerminated

Senna (sennosides 8.8 mg) Syrup, 8 fl oz. (237 mL) bottles, Rij Pharmaceuticals Corporation 40 Commercial Avenue, Middletown, NY 10941, NDC 53807-556-08

Geritrex, LLC

Failed Impurities/Degradation Specifications: Atypical odor and unpleasant taste was reported

May 6, 2019 · DrugView details →

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. NDC 68382-196-10

Zydus Pharmaceuticals USA Inc

CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.

May 6, 2019 · DrugView details →

Class IITerminated

Pramipexole Dihydrochloride Tablets 0.25 mg, 1000-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India. NDC 68382-197-10

Zydus Pharmaceuticals USA Inc

CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.

May 6, 2019 · DrugView details →

Class IITerminated

MethylPREDNISolone Tablets, USP 32 mg, 25 tablets, Rx Only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India NDC 68382-919-11

Zydus Pharmaceuticals USA Inc

CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.

May 6, 2019 · DrugView details →

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 68382-199-16

Zydus Pharmaceuticals USA Inc

CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.

May 6, 2019 · DrugView details →

Class IITerminated

Bevacizumab 2.5 mg/0.1 mL, packaged in a Prefilled Syringe, Rx only, AVELLA SPECIALTY PHARMACY 24416 N. 19TH AVENUE PHOENIX, AZ 85085, NDC 42852-001-27

Avella of Deer Valley, Inc. Store 38

Lack of assurance of sterility

May 3, 2019 · DrugView details →

Class IITerminated

Losartan Potassium Tablets USP 100 mg 90 film coated tablets Manufactured by: Vivimed Life Sciences Private Limited, Plot No. 101, 102, 107 & 108 SIDCO Pharmaceutical Complex, Alathur, Kanchipuram - 603 110, Tamilnadu, India. Manufactured for: Heritage Pharmaceuticals Inc., East Brunswick, NJ 08816. 1-866-901-DRUG (3784) NDC 23155-646-09

Heritage Pharmaceuticals, Inc.

CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level at the manufacturer

May 3, 2019 · DrugView details →

Class IITerminated

Losartan Potassium Tablets USP 50 mg 90 film coated tablets Manufactured by: Vivimed Life Sciences Private Limited, Plot No. 101, 102, 107 & 108 SIDCO Pharmaceutical Complex, Alathur, Kanchipuram - 603 110, Tamilnadu, India. Manufactured for: Heritage Pharmaceuticals Inc., East Brunswick, NJ 08816. 1-866-901-DRUG (3784) NDC 23155-645-09

Heritage Pharmaceuticals, Inc.

CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level at the manufacturer

May 3, 2019 · DrugView details →

Class IITerminated

Losartan Potassium Tablets USP 25 mg 90 film coated tablets Rx Only Manufactured by: Vivimed Life Sciences Private Limited, Plot No. 101, 102, 107 & 108 SIDCO Pharmaceutical Complex, Alathur, Kanchipuram - 603 110, Tamilnadu, India. Manufactured for: Heritage Pharmaceuticals Inc., East Brunswick, NJ 08816. 1-866-901-DRUG (3784) NDC 23155-644-09

Heritage Pharmaceuticals, Inc.

CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level at the manufacturer

May 3, 2019 · DrugView details →

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