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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 III

Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals), 100 mg, 100 Capsules (10 x 10), 10-count blisters per card, 10 cards per carton, Unit Dose NDC 68084-446-11, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC: 68084-446-01

by American Health Packaging

Reason
Failed Dissolution Specifications: Nitrofurantoin Capsules recalled due to dissolution failure at 0-time of the repackaged lot. Drug release results were above specification at 0-time.
Published
May 25, 2022
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

Cyanocobalamin Injection, USP, 1000 mcg per mL, For Intramuscular or Subcutaneous Use Only, 25 x 1 mL Vials, Rx only, Manufactured by: Eugia Pharma Specialties Limited, Hyderabad India for BluePoint Laboratories. NDC for Carton: 68001-509-60; NDC for vial: 68001-509-59

by American Health Packaging

Reason
Subpotent Drug: Out of specification for assay.
Published
May 4, 2022
Distribution
Alabama

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FDA Recall Terminated Historical recordClass II

Oxycodone Hydrochloride Oral Solution, USP (C-II), 5 mg/5 mL, Delivers 5 mL per Cup, 1 Tray of 10 Cups, Rx Only, For Institutional Use Only, American Health Packaging, Columbus, OH 43217. UPC (01) 003 60687 406 40 4; Case NDC#: 60687-406-77, Unit Dose NDC#: 60687-406-40

by American Health Packaging

Reason
Impurity failure at 0-time of the repackaged lot.
Published
March 16, 2022
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Metoprolol Succinate Extended-Release Tablets, USP 50 mg, 500-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013 INDIA. NDC 68001-501-03

by American Health Packaging

Reason
Failed Dissolution Specifications
Published
February 2, 2022
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

GlipiZIDE Extended-Release Tablets, 2.5 mg, 30 Tablets (3 blister cards each with 10 individually blistered doses), Rx only, Manufactured by: Patheon Pharmaceuticals Inc., Cincinnati, OH 45237; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054. Carton NDC#: 68084-295-21 (Individual Dose NDC: 68084-295-11)

by American Health Packaging

Reason
Failed Dissolution Specifications: results were above specification.
Published
October 27, 2021
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Valproic Acid Oral Solution, USP, 500 mg/10 mL, 100 10 mL unit dose cups per case, Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217 Case NDC#: 60687-262-56; Individual Dose NDC: 60687-262-42

by American Health Packaging

Reason
CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.
Published
October 6, 2021
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

Sirolimus Tablets 1 mg, 30 Tablets (5 blister cards x 6 unit doses), Rx only, Packaged and Distributed by: American Health Packaging Columbus, OH 43217, NDC 68084-915-25

by American Health Packaging

Reason
Failed Impurities/Degradation Specifications
Published
September 29, 2021
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Nitrofurantoin Capsules USP (Monohydrate/Macrocrystals), 100 mg, 100 per carton (10 capsules x 10 blister cards), Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC Carton: 68084-446-01; NDC Blister Card: 68084- 446-11

by American Health Packaging

Reason
Failed Dissolution Specifications
Published
January 27, 2021
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

Nabumetone Tablets, USP, 500 mg, 100 Tablets per carton (10 tablets x 10 blister cards), Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC carton: 60687-374-01, NDC unit dose: 60687-374-11

by American Health Packaging

Reason
Labeling Not Elsewhere Classified: The statement Pharmacist: Dispense with the accompanying Medication Guide was not included on the carton label.
Published
July 1, 2020
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Doxycycline Hyclate Tablets, USP, 100 mg, 30 Tablets per carton (3 x 10), 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 specification - dissolution results of 59% (spec. NLT 85%) at the 24 month time point (end of shelf life).
Published
June 17, 2020
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Ranitidine Tablets, USP, 150 mg, 100 Tablets (10 tablets x 10 blister card), Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC carton: 60687-322-01; NDC Unit Dose Card: 60687-322-11

by American Health Packaging

Reason
CGMP Deviations: Potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA.
Published
March 18, 2020
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Desmopressin Acetate Tablets, 0.2 mg, 30 tablets (3 x 10 unit dose blister cards), Rx Only, Packaged and distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 68084-604-21; NDC Unit Dose 68084-604-11

by American Health Packaging

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