FDA Recall
TerminatedTerminated: February 1, 2017Historical recordClass II
COMBIVENT RESPIMAT (ipratropium bromide and albuterol) Inhalation Spray, 20 mcg/100 mcg per actuation*, 4 Grams, 120 Metered Doses per inhaler, Rx only, Distributed by Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT 06877 USA, Made in Germany, NDC 0597-0024-02.
by Boehringer Ingelheim Roxane Inc
- Reason
- Defective Delivery System: Inhalers do not spray properly, emitting either no spray or a short transient spray.
- Published
- August 5, 2015
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: May 15, 2017Historical recordClass III
Intermezzo (zolpidem tartrate), sublingual tablet 3.5 mg, 1 tablet per pouch, 30 pouches per carton, Rx only, Distributed by Purdue Pharma L.P. Stamford, CT 06901-3431, NDC 59011-265-30
by Purdue Pharma L.P.
- Reason
- Failed dissolution specifications
- Published
- July 29, 2015
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: May 9, 2018Historical recordClass II
Captopril Tablets, USP, 100 mg Tablets, 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: 64679-0905-01.
by Wockhardt Usa Inc.
- Reason
- CGMP Deviations: Firm did not adequately investigate customer complaints.
- Published
- July 29, 2015
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: May 9, 2018Historical recordClass II
Captopril Tablets, USP, 50 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-0904-01) and B) 1000 Count Bottles (NDC: 64679-0904-02), 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
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FDA Recall
TerminatedTerminated: May 9, 2018Historical recordClass II
Captopril Tablets, USP, 25 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-0903-01) and B) 1000 Count Bottles (NDC: 64679-0903-02), 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
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FDA Recall
TerminatedTerminated: May 9, 2018Historical recordClass II
Zonisamide Capsules, 25 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: 64679-0945-01.
by Wockhardt Usa Inc.
- Reason
- CGMP Deviations: Firm did not adequately investigate customer complaints.
- Published
- July 29, 2015
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: May 9, 2018Historical recordClass II
Zonisamide Capsules, 50 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: 64679-0946-01.
by Wockhardt Usa Inc.
- Reason
- CGMP Deviations: Firm did not adequately investigate customer complaints.
- Published
- July 29, 2015
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: May 9, 2018Historical recordClass II
Metoprolol Succinate Extended-Release Tablets, USP, 25 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-0734-02), B) 500 Count Bottles (NDC: 64679-0734-03), C) 8000 Count Pouches, For Repacking Only (NDC: 64679-734-08) and D) 12 x 30 Tablet Dispenser Pack Cartons (NDC: 64679-0734-09), 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, 50 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-0735-02), B) 500 Count Bottles (NDC: 64679-0735-03), C) 4000 Count Pouches, For Repacking Only (NDC: 64679-0735-08), and D) 12 x 30 Tablet Dispenser Pack Cartons (NDC: 64679-0735-09), 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, 100 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-0736-02), B) 500 Count Bottles (NDC: 64679-0736-03), and C) 12 x 30 Tablet Dispenser Pack Cartons (NDC: 64679-0736-09), 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, 30 mg Capsules, Packaged in A) 30 Count Bottles (NDC: 64679-0670-01), B) 90 Count Bottles (NDC: 64679-0670-07), and C) 1000 Count Bottles (NDC: 64679-0670-05), 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
Lansoprazole Delayed-Release Capsules, USP, 15 mg Capsules, 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: 64679-0669-01.
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
Famotodine Tablets, USP, 10 mg Tablets, For Repacking Only, Packaged in 50,000 Count Drums, Over the Counter. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-0972-00.
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, 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 →
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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