American Health Packaging

FDA Regulatory Profile

Summary

Total Recalls
59 (2 Class I)
510(k) Clearances
0
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
D-0880-2022Class IIINitrofurantoin Capsules, USP (Monohydrate/Macrocrystals), 100 mg, 100 Capsules (10 x 10), 10-count bMay 3, 2022
D-0790-2022Class IIICyanocobalamin Injection, USP, 1000 mcg per mL, For Intramuscular or Subcutaneous Use Only, 25 x 1 mApril 12, 2022
D-0652-2022Class IIOxycodone Hydrochloride Oral Solution, USP (C-II), 5 mg/5 mL, Delivers 5 mL per Cup, 1 Tray of 10 CuFebruary 22, 2022
D-0451-2022Class IIMetoprolol Succinate Extended-Release Tablets, USP 50 mg, 500-count bottle, Rx Only, Manufactured byDecember 20, 2021
D-0020-2022Class IIGlipiZIDE Extended-Release Tablets, 2.5 mg, 30 Tablets (3 blister cards each with 10 individually blSeptember 17, 2021
D-0854-2021Class IIValproic Acid Oral Solution, USP, 500 mg/10 mL, 100 10 mL unit dose cups per case, Rx Only, PackagedSeptember 15, 2021
D-0813-2021Class IIISirolimus Tablets 1 mg, 30 Tablets (5 blister cards x 6 unit doses), Rx only, Packaged and DistributMay 12, 2021
D-0232-2021Class IINitrofurantoin Capsules USP (Monohydrate/Macrocrystals), 100 mg, 100 per carton (10 capsules x 10 blJanuary 7, 2021
D-1372-2020Class IIINabumetone Tablets, USP, 500 mg, 100 Tablets per carton (10 tablets x 10 blister cards), Rx only, DiJune 10, 2020
D-1293-2020Class IIDoxycycline Hyclate Tablets, USP, 100 mg, 30 Tablets per carton (3 x 10), Rx only, Distributed by: AMay 19, 2020
D-0848-2020Class IIDesmopressin Acetate Tablets, 0.1 mg, 30 tablets (3 x 10 unit dose blister cards), Rx Only, PackagedFebruary 7, 2020
D-0849-2020Class IIDesmopressin Acetate Tablets, 0.2 mg, 30 tablets (3 x 10 unit dose blister cards), Rx Only, PackagedFebruary 7, 2020
D-0854-2020Class IIRaloxifene Hydrochloride Tablets, USP, 60 mg, 30 Tablets (3 x 10 blister cards), Rx Only, Packaged aDecember 4, 2019
D-1003-2020Class IIRanitidine Tablets, USP, 150 mg, 100 Tablets (10 tablets x 10 blister card), Rx Only, Packaged and DNovember 20, 2019
D-0631-2020Class IIRanitidine Syrup (Ranitidine Oral Solution USP), 15 mg/mL, 150 mg/10 mL per cup, Rx Only, DistributeNovember 1, 2019
D-1847-2019Class IIILamivudine Tablets, USP, 150 mg, 30 (3x10) count Unit Dose Blisters Carton, NDC 60687-362-21 (IndiviAugust 27, 2019
D-1821-2019Class IICarbamazepine, Extended-Release Tablets, USP, 400 mg, 30 Tablets (3 blister cards x 10 unit doses), August 9, 2019
D-1433-2019Class IIPramipexole Dihydrochloride Tablets, 0.5 mg, 30 Tablets (6 tablets per blister card), Rx Only, DistrMay 13, 2019
D-1432-2019Class IIPramipexole Dihydrochloride Tablets, 0.25 mg, 100 Tablets (10 x 10), Rx Only, Packaged and DistributMay 13, 2019
D-1434-2019Class IIPramipexole Dihydrochloride Tablets, 1.0 mg, 30 Tablets (6 tablets per blister card), Rx Only, DistrMay 13, 2019