Skip to main content
Get Alerts

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
Download CSV

FDA Recall Terminated Historical recordClass II

Desmopressin Acetate Tablets, 0.1 mg, 30 tablets (3 x 10 unit dose blister cards), Rx Only, Packaged and distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 68084-606-21; NDC Unit Dose 68084-606-11

by American Health Packaging

Reason
GMP Deviations: Product bottle may be absent of desiccant.
Published
February 26, 2020
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

Raloxifene Hydrochloride Tablets, USP, 60 mg, 30 Tablets (3 x 10 blister cards), Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC carton: 60687-266-21; NDC Unit Dose: 60687-266-11

by American Health Packaging

Reason
Failed Dissolution Specifications: Low out of specification results obtained during stability testing.
Published
February 19, 2020
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

Ranitidine Syrup (Ranitidine Oral Solution USP), 15 mg/mL, 150 mg/10 mL per cup, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio. (a) Case of 50 cups (NDC 60687-260-69) (b) Case of 40 cups (NDC 60687-260-23 (c) Unit Dose Cup (NDC 60687-260-69)

by American Health Packaging

Reason
CGMP Deviations: Presence of NDMA impurity detected in product.
Published
January 8, 2020
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass III

Lamivudine Tablets, USP, 150 mg, 30 (3x10) count Unit Dose Blisters Carton, NDC 60687-362-21 (Individual Dose NDC: 60687-362-11), Distributed by American Health Packaging, Columbus, OH

by American Health Packaging

Reason
Labeling: Incorrect or Missing Package Insert; an error in the Dosage Forms and Strengths section of the insert that incorrectly lists the tablet description coding for the tablets.
Published
September 18, 2019
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

Carbamazepine, Extended-Release Tablets, USP, 400 mg, 30 Tablets (3 blister cards x 10 unit doses), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 68084-562-21; NDC Unit Dose: 68084-562-11

by American Health Packaging

Reason
Failed Dissolution Specifications
Published
August 21, 2019
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

Aspirin and Extended-release Dipyridamole Capsules, 25 mg/200 mg, 20 capsules per carton (5 blister cards x 4 unit doses), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 60687-305-32; NDC Blister Pack: 60687-305-33

by American Health Packaging

Reason
Failed Impurities/Degradation Specifications; out of specification result for an unknown impurity in stability samples.
Published
August 21, 2019
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass III

Lovastatin Tablets USP, 40 mg, packaged in a) 100-count bottles (NDC 68001-316-00) and b)1000-count bottles (NDC 68001-316-08), Rx Only, Manufactured by: Lupin Limited, Goa 403 722 INDIA For BluePoint Laboratories.

by American Health Packaging

Reason
CGMP Deviations: Finished product made with lovastatin drug substance that was out of specification for individual impurity results.
Published
August 14, 2019
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

Doxycycline Hyclate Tablets, USP, 100 mg, 30 Tablets per carton (3 x 10 Unit Dose Blisters), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio, 43217, NDC Carton: 62584-693-21; NDC Unit Dose: 62584-693-11

by American Health Packaging

Reason
Failed Dissolution Specifications: Out of specification result for the dissolution test.
Published
August 7, 2019
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

Anastrozole Tablets, USP, 1 mg, a) 30-count (NDC 68001-155-04) and 1000-count (NDC 68001-155-08) bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd., Ahmedabad, India For BluePoint Laboratories

by American Health Packaging

Reason
GMP Deviations: Potential cross contamination due to cleaning procedure failure.
Published
July 17, 2019
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

Pramipexole Dihydrochloride Tablets, 1.0 mg, 30 Tablets (6 tablets per blister card), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217 NDC Blister Card: 68084-982-95; NDC Carton: 68084-982-25

by American Health Packaging

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

View recall →

FDA Recall Terminated Historical recordClass II

Pramipexole Dihydrochloride Tablets, 0.5 mg, 30 Tablets (6 tablets per blister card), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217 NDC Blister Card: 68084-974-95; NDC Carton: 68084-974-25

by American Health Packaging

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

View recall →

FDA Recall Terminated Historical recordClass II

Pramipexole Dihydrochloride Tablets, 0.25 mg, 100 Tablets (10 x 10), Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217 NDC Blister Card: 68084-440-11; NDC Carton: 68084-440-01

by American Health Packaging

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

View recall →

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.