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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug

American Health Packaging: CGMP Deviations: Firm did not adequately investigate customer complaints.

Agency Publication Date: July 8, 2015
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Affected Products

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 for American Health Packaging 2550-A John Glenn Avenue, Columbus, OH 43217.

Lot #: 131924, Exp 07/31/2015

Lot Numbers:
131924
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 American Health Packaging 2550-A John Glenn Avenue, Columbus, OH 43217.

Lot#: 131954, 131955, Exp 08/31/2015

Lot Numbers:
131954
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 for American Health Packaging 2550-A John Glenn Avenue, Columbus, OH 43217.

Lot#: 131953, Exp 07/31/2015

Lot Numbers:
131953
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 American Health Packaging 2550-A John Glenn Avenue, Columbus, OH 43217.

Lot#: 134419A, Exp 12/31/2015; Lot#: 193441B, Exp 02/29/2016; Lot#: 133684B, Exp 09/30/2015.

Lot Numbers:
134419A
193441B
133684B
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 American Health Packaging 2550-A John Glenn Avenue, Columbus, OH 43217.

Lot#: 134420, 142540, Exp 7/31/2015

Lot Numbers:
134420
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 American Health Packaging 2550-A John Glenn Avenue, Columbus, OH 43217.

Lot#: 134392, Exp 06/30/2015

Lot Numbers:
134392
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 American Health Packaging 2550-A John Glenn Avenue, Columbus, OH 43217.

Lot#: 132323, Exp 07/31/2015; Lot#: 132960, Exp 09/30/2015; Lot#: 133707A, Exp 10/31/2015; Lot#: 133707B, Exp 11/30/2015.

Lot Numbers:
132323
132960
133707A
133707B
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 American Health Packaging 2550-A John Glenn Avenue, Columbus, OH 43217.

Lot#: 132146, Exp 06/30/2015; Lot#: 132147, 132963, Exp 08/31/2015; Lot#: 132964, Exp 10/31/2015; Lot#: 134319, Exp 12/31/2015; Lot#: 134320, Exp 01/31/2016.

Lot Numbers:
132146
132147
132964
134319
134320
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 Health Packaging 2550-A John Glenn Avenue, Columbus, OH 43217.

Lot#: 131928, Exp 09/30/2015

Lot Numbers:
131928
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 Health Packaging 2550-A John Glenn Avenue, Columbus, OH 43217.

Lot#: 131933, Exp 07/31/2015

Lot Numbers:
131933
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 Health Packaging 2550-A John Glenn Avenue, Columbus, OH 43217.

Lot#: 131934, Exp 09/30/2015

Lot Numbers:
131934
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 Health Packaging 2550-A John Glenn Avenue, Columbus, OH 43217.

Lot#: 131935, Exp 08/31/2015

Lot Numbers:
131935
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 American Health Packaging 2550-A John Glenn Avenue, Columbus, OH 43217.

Lot#: 132383: Exp Date: 07/31/2015; Lot#: 132989 Exp Date: 10/31/2015; Lot#: 133694 Exp Date: 03/31/2016l Lot#: 134418A Exp Date: 07/31/2016 & Lot#: 134418B Exp Date: 07/31/2016.

Lot Numbers:
132383
132989
133694
134418A
134418B

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 71553
Status: Resolved
Manufacturer: American Health Packaging
Manufactured In: United States
Units Affected: 13 products (1,896 cartons; 20,855 cartons; 1,745 cartons; 2,558 cartons; 838 cartons; 2,068 cartons; 3,572 cartons; 97,837 cartons; 4,718 cartons; 13,532 cartons; 5,591 cartons; 1,516 cartons; 5,416 cartons)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.