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American Health Packaging FDA Recalls
9 recalls on file across drugs, 0 of them Class I and 1 still open. This firm is not matched to a listed company.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Buprenorphine Sublingual Tablets (C-III), 2 mg, 30 Tablets (3x10), Rx only, Distributed by: American Health Packaging, CClass IIIAug 19, 2026Labeling: Label Mix-up |
| Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals), 100 mg, 100 Capsules (10 x 10), 10-count blisters per card, 10Class IIIMay 3, 2022Failed Dissolution Specifications: Nitrofurantoin Capsules r |
| Cyanocobalamin Injection, USP, 1000 mcg per mL, For Intramuscular or Subcutaneous Use Only, 25 x 1 mL Vials, Rx only, MaClass IIIApr 12, 2022Subpotent Drug: Out of specification for assay. |
| Oxycodone Hydrochloride Oral Solution, USP (C-II), 5 mg/5 mL, Delivers 5 mL per Cup, 1 Tray of 10 Cups, Rx Only, For InsClass IIFeb 22, 2022Impurity failure at 0-time of the repackaged lot. |
| Metoprolol Succinate Extended-Release Tablets, USP 50 mg, 500-count bottle, Rx Only, Manufactured by: Alkem LaboratoriesClass IIDec 20, 2021Failed Dissolution Specifications |
| GlipiZIDE Extended-Release Tablets, 2.5 mg, 30 Tablets (3 blister cards each with 10 individually blistered doses), Rx oClass IISep 17, 2021Failed Dissolution Specifications: results were above specif |
| Valproic Acid Oral Solution, USP, 500 mg/10 mL, 100 10 mL unit dose cups per case, Rx Only, Packaged and Distributed by:Class IISep 15, 2021CGMP Deviations: Potential concern with products manufacture |
| Sirolimus Tablets 1 mg, 30 Tablets (5 blister cards x 6 unit doses), Rx only, Packaged and Distributed by: American HealClass IIIMay 12, 2021Failed Impurities/Degradation Specifications |
| Nitrofurantoin Capsules USP (Monohydrate/Macrocrystals), 100 mg, 100 per carton (10 capsules x 10 blister cards), Rx onlClass IIJan 7, 2021Failed Dissolution Specifications |