American Health Packaging

50 FDA enforcement records linked to this company.

• recall — Class III2022-05-25

  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.

• recall — Class III2022-05-04

  Subpotent Drug: Out of specification for assay.

• recall — Class II2022-03-16

  Impurity failure at 0-time of the repackaged lot.

• recall — Class II2022-02-02

  Failed Dissolution Specifications

• recall — Class II2021-10-27

  Failed Dissolution Specifications: results were above specification.

• recall — Class II2021-10-06

  CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.

• recall — Class III2021-09-29

  Failed Impurities/Degradation Specifications

• recall — Class II2021-01-27

  Failed Dissolution Specifications

• recall — Class III2020-07-01

  Labeling Not Elsewhere Classified: The statement Pharmacist: Dispense with the accompanying Medication Guide was not included on the carton label.

• recall — Class II2020-06-17

  Failed dissolution specification - dissolution results of 59% (spec. NLT 85%) at the 24 month time point (end of shelf life).

• recall — Class II2020-03-18

  CGMP Deviations: Potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA.

• recall — Class II2020-02-26

  GMP Deviations: Product bottle may be absent of desiccant.

• recall — Class II2020-02-26

  GMP Deviations: Product bottle may be absent of desiccant.

• recall — Class II2020-02-19

  Failed Dissolution Specifications: Low out of specification results obtained during stability testing.

• recall — Class II2020-01-08

  CGMP Deviations: Presence of NDMA impurity detected in product.