FDA (Drugs) recall action 71104

Wockhardt Usa Inc. recalled 35 products on 2015-07-29

The FDA (Drugs) publishes a recall like this one as 35 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 35 pages.

Products: 35
Announced: 2015-07-29
Critical: 0
Units: 1,428,502

Why these products were recalled

CGMP Deviations: Firm did not adequately investigate customer complaints.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–25 of 35

ModerateFDA (Drugs)··2015-07-29
Wockhardt Recalls Azithromycin Tablets Due to Complaint Investigation Failures
Wockhardt USA is recalling 7,584 bottles of Azithromycin 600 mg tablets because the firm did not adequately investigate customer complaints.
Product
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.
Category
Distribution
1 state
ModerateFDA (Drugs)··2015-07-29
Wockhardt Recalls Famotodine Tablets Due to CGMP Deviations
Wockhardt USA is recalling 539 drums of Famotodine Tablets, 20 mg, because the firm did not adequately investigate customer complaints.
Product
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.
Category
Distribution
1 state
ModerateFDA (Drugs)··2015-07-29
Wockhardt Recalls Metoprolol Succinate Tablets Due to CGMP Deviations
Wockhardt USA Inc. is recalling Metoprolol Succinate Extended-Release Tablets because the firm did not adequately investigate customer complaints.
Product
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:
Category
Distribution
1 state
ModerateFDA (Drugs)··2015-07-29
Wockhardt Recalls Amlodipine Besylate Tablets Due to CGMP Deviations
Wockhardt USA LLC is recalling Amlodipine Besylate 2.5 mg tablets because the firm did not adequately investigate customer complaints.
Product
Amlodipine Besylate Tablets, 2.5 mg Tablets, Packaged in 90 Count Bottles, Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-421-01.
Category
Distribution
1 state
ModerateFDA (Drugs)··2015-07-29
Wockhardt Recalls Zolpidem Tartrate Tablets Due to Complaint Investigation Failures
Wockhardt USA is recalling Zolpidem Tartrate 5 mg tablets because the firm did not adequately investigate customer complaints.
Product
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.
Category
Distribution
1 state
ModerateFDA (Drugs)··2015-07-29
Wockhardt Recalls Famotodine Tablets Due to CGMP Deviations
Wockhardt USA Inc. is recalling Famotodine Tablets, USP, 40 mg due to inadequate investigation of customer complaints.
Product
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 2
Category
Distribution
1 state
ModerateFDA (Drugs)··2015-07-29
Wockhardt Recalls Lisinopril Tablets Due to Complaint Investigation Failures
Wockhardt USA is recalling Lisinopril 40 mg tablets because the firm did not adequately investigate customer complaints.
Product
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 W
Category
Distribution
1 state
ModerateFDA (Drugs)··2015-07-29
Wockhardt Recalls Lisinopril Tablets Due to CGMP Deviations
Wockhardt USA Inc. is recalling Lisinopril Tablets USP, 20 mg, due to inadequate investigation of customer complaints. The recall covers nationwide distribution.
Product
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
Category
Distribution
1 state
ModerateFDA (Drugs)··2015-07-29
Wockhardt Recalls Azithromycin Tablets Due to Complaint Investigation Failures
Wockhardt USA LLC is recalling Azithromycin Tablets, USP, 500 mg because the firm did not adequately investigate customer complaints.
Product
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 0
Category
Distribution
1 state
ModerateFDA (Drugs)··2015-07-29
Wockhardt Recalls Tamsulosin Hydrochloride Capsules Due to CGMP Deviations
Wockhardt USA Inc. is recalling Tamsulosin Hydrochloride Capsules because the firm did not adequately investigate customer complaints, a Current Good Manufacturing Practice (CGMP) deviation.
Product
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
Category
Distribution
1 state
ModerateFDA (Drugs)··2015-07-29
Wockhardt Recalls Captopril Tablets Due to CGMP Deviations
Wockhardt USA is recalling Captopril Tablets, USP, 25 mg due to inadequate investigation of customer complaints.
Product
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.
Category
Distribution
1 state
ModerateFDA (Drugs)··2015-07-29
Wockhardt Recalls 15 mg Lansoprazole Capsules Due to Complaint Investigation Failures
Wockhardt USA is recalling 848 pouches of 15 mg Lansoprazole Delayed-Release Capsules because the firm did not adequately investigate customer complaints.
Product
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
Category
Distribution
1 state
ModerateFDA (Drugs)··2015-07-29
Wockhardt Recalls Lansoprazole Capsules Due to Inadequate Complaint Investigation
Wockhardt USA is recalling specific lots of Lansoprazole Delayed-Release Capsules because the manufacturer did not adequately investigate customer complaints.
Product
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:
Category
Distribution
1 state
ModerateFDA (Drugs)··2015-07-29
Wockhardt Recalls Zonisamide Capsules Due to Inadequate Complaint Investigation
Wockhardt USA is recalling Zonisamide Capsules, 25 mg, because the firm did not adequately investigate customer complaints.
Product
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.
Category
Distribution
1 state
ModerateFDA (Drugs)··2015-07-29
Wockhardt Recalls Amlodipine Besylate Tablets Due to CGMP Deviations
Wockhardt USA is recalling Amlodipine Besylate 5 mg tablets because the firm did not adequately investigate customer complaints.
Product
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
Category
Distribution
1 state
ModerateFDA (Drugs)··2015-07-29
Wockhardt Recalls Captopril Tablets Due to Inadequate Complaint Investigation
Wockhardt USA is recalling Captopril 50 mg tablets because the manufacturer did not adequately investigate customer complaints.
Product
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.
Category
Distribution
1 state
ModerateFDA (Drugs)··2015-07-29
Wockhardt Recalls Metoprolol Succinate Extended-Release Tablets Due to CGMP Deviations
Wockhardt USA Inc. is recalling Metoprolol Succinate Extended-Release Tablets, 100 mg, because the firm did not adequately investigate customer complaints.
Product
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, Mu
Category
Distribution
1 state
ModerateFDA (Drugs)··2015-07-29
Wockhardt Recalls Lisinopril Tablets Due to Complaint Investigation Failures
Wockhardt USA is recalling specific lots of Lisinopril 30 mg tablets because the firm did not adequately investigate customer complaints.
Product
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.
Category
Distribution
1 state
ModerateFDA (Drugs)··2015-07-29
Wockhardt Recalls Famotidine Tablets Due to Complaint Investigation Failures
Wockhardt USA LLC is recalling 1,002 drums of Famotidine Tablets, USP, 10 mg because the firm did not adequately investigate customer complaints.
Product
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.
Category
Distribution
1 state
ModerateFDA (Drugs)··2015-07-29
Wockhardt Recalls Lisinopril Tablets Due to Inadequate Complaint Investigation
Wockhardt USA is recalling Lisinopril 10 mg tablets because the firm did not adequately investigate customer complaints. The recall covers multiple lot numbers distributed nationwide.
Product
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 W
Category
Distribution
1 state
ModerateFDA (Drugs)··2015-07-29
Wockhardt Recalls 15 mg Lansoprazole Capsules Due to CGMP Deviations
Wockhardt USA is recalling 16,276 bottles of 15 mg Lansoprazole Delayed-Release Capsules because the firm did not adequately investigate customer complaints.
Product
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.
Category
Distribution
1 state
ModerateFDA (Drugs)··2015-07-29
Wockhardt Recalls Famotodine Tablets Due to Complaint Investigation Failures
Wockhardt USA is recalling Famotodine Tablets 20 mg because the company did not adequately investigate customer complaints, a CGMP deviation.
Product
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
Category
Distribution
1 state
ModerateFDA (Drugs)··2015-07-29
Wockhardt Recalls Clarithromycin Tablets Due to Complaint Investigation Failures
Wockhardt USA is recalling 59,729 bottles of Clarithromycin 500 mg tablets because the firm did not adequately investigate customer complaints.
Product
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.
Category
Distribution
1 state
ModerateFDA (Drugs)··2015-07-29
Wockhardt Recalls Zolpidem Tartrate Tablets Due to Complaint Investigation Failures
Wockhardt USA is recalling Zolpidem Tartrate 10 mg tablets because the company did not adequately investigate customer complaints, a violation of current Good Manufacturing Practices.
Product
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 0705
Category
Distribution
1 state
ModerateFDA (Drugs)··2015-07-29
Wockhardt Recalls Amlodipine Besylate Tablets Due to CGMP Deviations
Wockhardt USA is recalling Amlodipine Besylate 10 mg tablets because the firm did not adequately investigate customer complaints.
Product
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 U
Category
Distribution
1 state