FDA (Drugs) recall action 71553

American Health Packaging recalled 13 products on 2015-07-15

The FDA (Drugs) publishes a recall like this one as 13 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 13 pages.

Products: 13
Announced: 2015-07-15
Critical: 0
Units: 162,142

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.

1–13 of 13

ModerateFDA (Drugs)··2015-07-15
Amlodipine besylate tablets recalled for inadequate complaint investigation
American Health Packaging is recalling 1,896 cartons of Amlodipine besylate tablets 2.5mg due to inadequate investigation of customer complaints.
Product
Amlodipine besylate tablets, USP 2.5mg, packaged in 10-count blisters (NDC 68084-498-11); 10 blister packs per carton (NDC 68084-498-01); Rx only, Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA f
Category
Distribution
0 states
ModerateFDA (Drugs)··2015-07-15
Zonisamide capsules recalled for inadequate complaint investigation
American Health Packaging is recalling Zonisamide capsules due to current good manufacturing practice deviations involving inadequate investigation of customer complaints.
Product
Zonisamide capsules, USP 100mg packaged in 10-count blisters (NDC 68084-008-11); 5 blister packs per carton (NDC 68084-008-65); Rx only, Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA for America
Category
Distribution
0 states
ModerateFDA (Drugs)··2015-07-15
American Health Packaging Recalls Azithromycin Tablets Due to CGMP Deviations
American Health Packaging is recalling specific lots of Azithromycin tablets because the firm did not adequately investigate customer complaints.
Product
Azithromycin tablets, USP 500mg, packaged in 10-count blisters (NDC 68084-279-11); 3 blister packs per carton (NDC 68084-279-21); Rx only, Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA for Ameri
Category
Distribution
0 states
ModerateFDA (Drugs)··2015-07-15
Amlodipine besylate tablets recalled for inadequate complaint investigation
American Health Packaging is recalling Amlodipine besylate tablets 10 mg due to current Good Manufacturing Practice (CGMP) deviations involving inadequate investigation of customer complaints.
Product
Amlodipine besylate tablets, USP 10 mg, packaged in 10-count blisters (NDC 68084-506-11); 10 blister packs per carton (NDC 68084-506-01); Rx only, Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA f
Category
Distribution
0 states
ModerateFDA (Drugs)··2015-07-15
Famotidine tablets recalled for inadequate complaint investigation
American Health Packaging is recalling 97,837 cartons of Famotidine tablets 20mg due to CGMP deviations involving inadequate investigation of customer complaints.
Product
Famotidine tablets, USP 20mg, packaged in 10-count blisters (NDC 68084-172-11); 10 blister packs per carton (NDC 68084-172-01); Rx only, Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA for America
Category
Distribution
0 states
ModerateFDA (Drugs)··2015-07-15
American Health Packaging Recalls Azithromycin Tablets Due to Complaint Investigation Failures
American Health Packaging is recalling 838 cartons of Azithromycin 600mg tablets because the firm did not adequately investigate customer complaints.
Product
Azithromycin tablets, USP 600mg, packaged in 10-count blisters (NDC 68084-464-11); 3 blister packs per carton (NDC 68084-464-21); Rx only, Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA for Ameri
Category
Distribution
0 states
ModerateFDA (Drugs)··2015-07-15
American Health Packaging Recalls Clarithromycin Tablets Due to CGMP Deviations
American Health Packaging is recalling 3,572 cartons of Clarithromycin tablets, USP 500mg, because the firm did not adequately investigate customer complaints.
Product
Clarithromycin tablets, USP 500mg, packaged in 10-count blisters (NDC 68084-437-11); 5 blister packs per carton (NDC 68084-279-65); Rx only, Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA for Ame
Category
Distribution
0 states
ModerateFDA (Drugs)··2015-07-15
American Health Packaging Recalls Lisinopril Tablets Due to CGMP Deviations
American Health Packaging is recalling 4,718 cartons of Lisinopril 5mg tablets due to inadequate investigation of customer complaints.
Product
Lisinopril tablets, USP 5mg packaged in 10-count blisters (NDC 68084-060-11); 10 blister packs per carton (NDC 68084-060-01); Rx only, Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA for American
Category
Distribution
0 states
ModerateFDA (Drugs)··2015-07-15
American Health Packaging Recalls Lisinopril Tablets Due to CGMP Deviations
American Health Packaging is recalling Lisinopril tablets 40mg due to inadequate investigation of customer complaints. The recall covers 1,516 cartons distributed nationwide.
Product
Lisinopril tablets, USP 40mg packaged in 10-count blisters (NDC 68084-064-11); 10 blister packs per carton (NDC 68084-064-01); Rx only, Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA for American
Category
Distribution
0 states
ModerateFDA (Drugs)··2015-07-15
American Health Packaging Recalls Azithromycin Tablets Due to CGMP Deviations
American Health Packaging is recalling 2,068 cartons of Azithromycin tablets 250mg due to inadequate investigation of customer complaints.
Product
Azithromycin tablets, USP 250mg, packaged in 10-count blisters (NDC 68084-278-11); 10 blister packs per carton (NDC 68084-278-01); Rx only, Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA for Amer
Category
Distribution
0 states
ModerateFDA (Drugs)··2015-07-15
American Health Packaging Recalls Lisinopril Tablets Due to CGMP Deviations
American Health Packaging is recalling 5,591 cartons of Lisinopril 20mg tablets nationwide because the firm did not adequately investigate customer complaints.
Product
Lisinopril tablets, USP 20mg packaged in 10-count blisters (NDC 68084-062-11); 10 blister packs per carton (NDC 68084-062-01); Rx only, Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA for American
Category
Distribution
0 states
ModerateFDA (Drugs)··2015-07-15
Amlodipine besylate tablets recalled for inadequate complaint investigation
American Health Packaging is recalling Amlodipine besylate tablets 5mg due to CGMP deviations involving inadequate investigation of customer complaints.
Product
Amlodipine besylate tablets, USP 5mg, packaged in 10-count blisters (NDC 68084-505-11); 10 blister packs per carton (NDC 68084-505-01); Rx only, Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA for
Category
Distribution
0 states
ModerateFDA (Drugs)··2015-07-15
American Health Packaging Recalls Lisinopril Tablets Due to Complaint Investigation Failures
American Health Packaging is recalling 13,532 cartons of Lisinopril 10mg tablets because the firm did not adequately investigate customer complaints.
Product
Lisinopril tablets, USP 10mg packaged in 10-count blisters (NDC 68084-061-11); 10 blister packs per carton (NDC 68084-061-01); Rx only, Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA for American
Category
Distribution
0 states