FDA Recall
TerminatedTerminated: May 9, 2018Historical recordClass II
Famotodine Tablets, USP, 20 mg Tablets, For Repacking Only, Packaged in 6500 Count Drums, Over the Counter. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-0374-09.
by Wockhardt Usa Inc.
- Reason
- CGMP Deviations: Firm did not adequately investigate customer complaints.
- Published
- July 29, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: May 9, 2018Historical recordClass II
Famotodine Tablets, USP, 20 mg Tablets, Packaged in A) 30 Count Bottles (NDC: 64679-936-01), B) 100 Count Bottles(NDC: 64679-936-02), and C) 1000 Count Bottles (NDC: 64679-936-03), Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA.
by Wockhardt Usa Inc.
- Reason
- CGMP Deviations: Firm did not adequately investigate customer complaints.
- Published
- July 29, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: May 9, 2018Historical recordClass II
Azithromycin Tablets, USP, 600 mg Tablets, Packaged in 30 Count Bottles, Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-962-01.
by Wockhardt Usa Inc.
- Reason
- CGMP Deviations: Firm did not adequately investigate customer complaints.
- Published
- July 29, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: May 9, 2018Historical recordClass II
Azithromycin Tablets, USP, 500 mg Tablets, Packaged in A) 30 Count Bottles (NDC: 64679-0964-01) and B) 3 x 3 Tablet Card Cartons (NDC: 64679-964-05), Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA.
by Wockhardt Usa Inc.
- Reason
- CGMP Deviations: Firm did not adequately investigate customer complaints.
- Published
- July 29, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: May 9, 2018Historical recordClass II
Zolpidem Tartrate Tablets, 10 mg Tablets, CIV, Packaged in A) 100 Count Bottles (NDC: 64679-715-01) and B) 500 Count Bottles (NDC: 64679-715-04), Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA.
by Wockhardt Usa Inc.
- Reason
- CGMP Deviations: Firm did not adequately investigate customer complaints.
- Published
- July 29, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: May 9, 2018Historical recordClass II
Lisinopril Tablets USP, 40 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-942-01), B) 500 Count Bottles (NDC: 64679-942-05), and C) 1000 Count Bottles (NDC: 64679-942-02), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA.
by Wockhardt Usa Inc.
- Reason
- CGMP Deviations: Firm did not adequately investigate customer complaints.
- Published
- July 29, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: May 9, 2018Historical recordClass II
Lisinopril Tablets USP, 30 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-953-01) and B) 500 Count Bottles (NDC: 64679-953-05), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA.
by Wockhardt Usa Inc.
- Reason
- CGMP Deviations: Firm did not adequately investigate customer complaints.
- Published
- July 29, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: May 9, 2018Historical recordClass II
Lisinopril Tablets USP, 20 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-941-01), B) 500 Count Bottles (NDC: 64679-941-05), and C) 1000 Count Bottles (NDC: 64679-941-06), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA.
by Wockhardt Usa Inc.
- Reason
- CGMP Deviations: Firm did not adequately investigate customer complaints.
- Published
- July 29, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: May 9, 2018Historical recordClass II
Lisinopril Tablets USP, 10 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-929-01), B) 500 Count Bottles (NDC: 64679-929-05), and C) 1000 Count Bottles (NDC: 64679-929-06), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA.
by Wockhardt Usa Inc.
- Reason
- CGMP Deviations: Firm did not adequately investigate customer complaints.
- Published
- July 29, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: May 9, 2018Historical recordClass II
Lisinopril Tablets USP, 5 mg Tablets,Packaged in A) 100 Count Bottles (NDC: 64679-928-01), B) 500 Count Bottles (NDC: 64679-928-05), and C) 1000 Count Bottles (NDC: 64679-928-06), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA.
by Wockhardt Usa Inc.
- Reason
- CGMP Deviations: Firm did not adequately investigate customer complaints.
- Published
- July 29, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: May 9, 2018Historical recordClass II
Amlodipine Besylate Tablets, 10 mg Tablets, Packaged as A) 90 Count Bottles (NDC: 64679-423-01) and B) 1000 Count Bottles (NDC: 64679-423-02, Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA.
by Wockhardt Usa Inc.
- Reason
- CGMP Deviations: Firm did not adequately investigate customer complaints.
- Published
- July 29, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: May 9, 2018Historical recordClass II
Amlodipine Besylate Tablets, 5 mg Tablets, Packaged as A) 90 Count Bottles (NDC: 64679-422-01) and B) 1000 Count Bottles (NDC: 64679-422-02), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA.
by Wockhardt Usa Inc.
- Reason
- CGMP Deviations: Firm did not adequately investigate customer complaints.
- Published
- July 29, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: May 9, 2018Historical recordClass II
Zonisamide Capsules, 100 mg Capsules, Packaged in 100 Count Bottles, Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-0990-01.
by Wockhardt Usa Inc.
- Reason
- CGMP Deviations: Firm did not adequately investigate customer complaints.
- Published
- July 29, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: May 9, 2018Historical recordClass II
Tamsulosin Hydrochloride Capsules, USP*, 0.4 mg Capsules, Packaged in A) 100 Count Bottles (NDC: 64679-516-02) and B) 500 Count Bottles (NDC: 64679-516-03), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA.
by Wockhardt Usa Inc.
- Reason
- CGMP Deviations: Firm did not adequately investigate customer complaints.
- Published
- July 29, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: May 9, 2018Historical recordClass II
Metoprolol Succinate Extended-Release Tablets, USP, 200 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-0737-02) and B) 500 Count Bottles (NDC: 64679-0737-03), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA .
by Wockhardt Usa Inc.
- Reason
- CGMP Deviations: Firm did not adequately investigate customer complaints.
- Published
- July 29, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: May 9, 2018Historical recordClass II
Lansoprazole Delayed-Release Capsules, USP, 15 mg Capsules, For Repackaging Only, Packaged in 4500 Count Pouches, Over the Counter. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-140-00.
by Wockhardt Usa Inc.
- Reason
- CGMP Deviations: Firm did not adequately investigate customer complaints.
- Published
- July 29, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: May 9, 2018Historical recordClass II
Famotodine Tablets, USP, 40 mg Tablets, Packaged in A) 30 Count Bottles (NDC: 64679-937-01), B) 100 Count Bottles (NDC: 64679-937-02), and C) 1000 Count Bottles (NDC: 64679-937-03), Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA.
by Wockhardt Usa Inc.
- Reason
- CGMP Deviations: Firm did not adequately investigate customer complaints.
- Published
- July 29, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: May 9, 2018Historical recordClass II
Clarithromycin Tablets, USP, 500 mg Tablets, 60 Count Bottles, Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-949-01.
by Wockhardt Usa Inc.
- Reason
- CGMP Deviations: Firm did not adequately investigate customer complaints.
- Published
- July 29, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: May 9, 2018Historical recordClass II
Azithromycin Tablets, USP, 250 mg Tablets, Packaged in A) 30 Count Bottles (NDC: 64679-0961-01), B) 3,500 Count Pouches (NDC: 64679-961-08), and C) 3 x 6 Tablet Card Cartons (NDC: 64679-961-05), Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA.
by Wockhardt Usa Inc.
- Reason
- CGMP Deviations: Firm did not adequately investigate customer complaints.
- Published
- July 29, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: May 9, 2018Historical recordClass II
Zolpidem Tartrate Tablets, 5 mg Tablets, CIV, Packaged in 100 Tablet Bottles, Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-714-01.
by Wockhardt Usa Inc.
- Reason
- CGMP Deviations: Firm did not adequately investigate customer complaints.
- Published
- July 29, 2015
- 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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