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

26–35 of 35

ModerateFDA (Drugs)··2015-07-29
Wockhardt Recalls Extended Phenytoin Sodium Capsules Due to CGMP Deviations
Wockhardt USA is recalling 53,894 bottles of Extended Phenytoin Sodium Capsules because the firm did not adequately investigate customer complaints.
Product
Extended Phenytoin Sodium Capsules, USP, 100 mg Capsules, Packaged as A) 100 Count Bottles (NDC: 64679-720-01) and B) 1000 Count Bottles (NDC: 64679-720-02), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippan
Category
Distribution
1 state
ModerateFDA (Drugs)··2015-07-29
Wockhardt Recalls Lamotrigine Extended-Release Tablets Due to CGMP Deviations
Wockhardt USA LLC is recalling 5,910 bottles of Lamotrigine Extended-Release Tablets, 25 mg, because the firm did not adequately investigate customer complaints.
Product
Lamotrigine Extended-Release Tablets, 25 mg Tablets, 30 Count Bottles, Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-271-01.
Category
Distribution
1 state
ModerateFDA (Drugs)··2015-07-29
Wockhardt Recalls Azithromycin Tablets Due to Complaint Investigation Failures
Wockhardt USA Inc. is recalling Azithromycin Tablets, USP, 250 mg because the firm did not adequately investigate customer complaints.
Product
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: Wockhard
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 2.5 mg tablets because the manufacturer did not adequately investigate customer complaints.
Product
Lisinopril Tablets USP, 2.5 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-927-01) and B) 500 Count Bottles (NDC: 64679-927-05), 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 Metoprolol Succinate Tablets Due to Complaint Investigation Failures
Wockhardt USA is recalling Metoprolol Succinate Extended-Release Tablets because the firm did not adequately investigate customer complaints.
Product
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: 64
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 specific lots of Metoprolol Succinate Extended-Release Tablets because the firm did not adequately investigate customer complaints.
Product
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
Category
Distribution
1 state
ModerateFDA (Drugs)··2015-07-29
Wockhardt Recalls Zonisamide Capsules Due to Complaint Investigation Failures
Wockhardt USA is recalling 84,542 bottles of Zonisamide 50 mg capsules because the firm did not adequately investigate customer complaints.
Product
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.
Category
Distribution
1 state
ModerateFDA (Drugs)··2015-07-29
Wockhardt Recalls Lisinopril Tablets Due to Inadequate Complaint Investigation
Wockhardt USA is recalling specific lots of Lisinopril 5 mg tablets because the firm did not adequately investigate customer complaints.
Product
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 Wat
Category
Distribution
1 state
ModerateFDA (Drugs)··2015-07-29
Wockhardt Recalls Captopril Tablets Due to Complaint Investigation Failures
Wockhardt USA is recalling 68,969 bottles of Captopril 100 mg tablets because the firm did not adequately investigate customer complaints.
Product
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.
Category
Distribution
1 state
ModerateFDA (Drugs)··2015-07-29
Wockhardt Recalls Zonisamide Capsules Due to Inadequate Complaint Investigation
Wockhardt USA LLC is recalling 491,360 bottles of Zonisamide Capsules, 100 mg, because the firm did not adequately investigate customer complaints.
Product
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.
Category
Distribution
1 state