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American Health Packaging

Recalls

Recalls by year

A bar chart of the number of recalls naming this company by year.

Recalls by year
YearRecalls
20122
20134
20146
201516
20183
201913
20207
20214
20224
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FDA Recall Terminated Historical recordClass II

Pramipexole Dihydrochloride Tablets, 0.125 mg, 30 Tablets (6 tablets per blister card), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217 NDC Blister Card: 68084-793-95; NDC Carton: 68084-793-25

by American Health Packaging

Reason
GMP Deviations; possible cross contamination of product due to cleaning procedure failure.
Published
July 3, 2019
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Anastrozole Tablets, USP, 1mg, 30-count unit dose blisters per carton, Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC 60687-112-21.

by American Health Packaging

Reason
GMP Deviations: Potential cross contamination due to cleaning procedure failure.
Published
June 26, 2019
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

GlipiZIDE Extended-release Tablets, 2.5 mg, 30 Tablets (3 x 10), Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC: 68084-295-21

by American Health Packaging

Reason
Failed Dissolution Specifications: dissolution failure at time zero of the repackaged lot. Drug release results were slightly above specification at time zero.
Published
May 8, 2019
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Valsartan Tablets USP 160 mg, 100 Tablets (10 x 10) per Unit Dose Blisters, Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217 (Individual Dose NDC:60687-139-11, Carton NDC#: 60687-139-01)

by American Health Packaging

Reason
CGMP Deviation: Presence of NDEA (N-Nitrosodimethylamine), a carcinogen impurity, detected in the active ingredient.
Published
March 27, 2019
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

Nitrofurantoin Capsules USP (Monohydrate/Macrocrystals), 100 mg, 100-count Unit Dose Blisters, Rx only, Amerisource Health Services DBA American Health Packaging, 2550-A John Glenn Avenue Columbus, OH 43217, NDC 68084-446-01 (Individual Dose NDC: 68064-446-11)

by American Health Packaging

Reason
Cross contamination with other products: This sub-recall is being initiated in support of the recall by the manufacturer (Sandoz) dated 11/1/18, which included lots that were repackaged by American Health Packaging. Sandoz stated that "These lots are being recalled due to the potential presence of unrelated ingredients (i.e. traces of active ingredients of Benazepril, Haloperidol and Perphenazine), which were identified through a manufacturing investigation."
Published
November 28, 2018
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

Enalapril Maleate Tablets USP, 5 mg, 100 Tablets (10X10) blister cards, 12 cartons in a shipper, Rx, Packaged and Distributed by: American Health Packaging, Columbus, OH --- NDC 68084-390-01 Carton [68084-390-11 - Unit Dose]

by American Health Packaging

Reason
Failed Impurities/Degradation Specification; out-of-specification results for the Enalapril DKT degradant
Published
July 18, 2018
Distribution
Lot#166023 products distributed from 12/…

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FDA Recall Terminated Historical recordClass II

Aripiprazole Tablets, USP, 10 mg, 100 Tablets (10 x 10) unit dose blisters [NDC60687-179-11; UPC (01) 003 60687 179 11 7] per carton (NDC 60687-179-01), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217.

by American Health Packaging

Reason
CGMP Deviations: lot made with active pharmaceutical ingredient that did not meet all its intended specifications.
Published
February 21, 2018
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

Desmopressin Acetate Tablets, 0.1 mg Tablets, Rx Only, Packed in 30 Tablet (3 x 10) Cartons. Packaged and Distributed by: American Health Packaging Columbus, Ohio 43217. NDC: 68084-606-21.

by American Health Packaging

Reason
Tablets/Capsules Imprinted with Wrong ID: Some tablets incorrectly imprinted with an X on one side.
Published
July 22, 2015
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

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.

by American Health Packaging

Reason
CGMP Deviations: Firm did not adequately investigate customer complaints.
Published
July 15, 2015
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

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.

by American Health Packaging

Reason
CGMP Deviations: Firm did not adequately investigate customer complaints.
Published
July 15, 2015
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

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.

by American Health Packaging

Reason
CGMP Deviations: Firm did not adequately investigate customer complaints.
Published
July 15, 2015
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

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.

by American Health Packaging

Reason
CGMP Deviations: Firm did not adequately investigate customer complaints.
Published
July 15, 2015
Distribution
Nationwide

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This page lists recalls that name American Health Packaging as the recalling firm in the official source notice. It is not a safety rating, ranking, or statement that the company acted negligently. Read the full medical disclaimer.