Manufacturer profile
Actavis Pharma, Inc.
Pharmaceutical company2 products tracked
2
products tracked
39,164
total reports
12
recalls on record
87.6%
serious overall
Products
showing 2 of 2
| Product | Approved | Reports ↓ | Top signal | Recalls |
|---|---|---|---|---|
| 1988 | 37,667 | Hepatic encephalopathy | 9 | |
| 1988 | 1,497 | Rebound acid hypersecretion | 3 |
Recall history · 11 on record
| Date | Class | Reason | Firm |
|---|---|---|---|
| Apr 26, 2023 | II | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. |
| Apr 26, 2023 | II | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. |
| Jan 7, 2020 | II | CGMP Deviations: Trace amounts of an impurity, N-nitrosodimethylamine (NDMA) was detected in the API Nizatidine. | Mylan Pharmaceuticals Inc. |
| Jan 7, 2020 | II | CGMP Deviations: Trace amounts of an impurity, N-nitrosodimethylamine (NDMA) was detected in the API Nizatidine. | Mylan Pharmaceuticals Inc. |
| May 21, 2019 | II | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii). | Torrent Pharma Inc |
| May 21, 2019 | II | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii). | Torrent Pharma Inc |
| Jun 26, 2017 | II | Microbial contamination of non-sterile product: product failed Total Yeast/Mold Count specification. | VistaPharm, Inc. |
| Jun 26, 2017 | II | Microbial contamination of non-sterile product: product failed Total Yeast/Mold Count specification. | VistaPharm, Inc. |
| Jan 18, 2017 | II | CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia. | VistaPharm, Inc. |
| Jan 18, 2017 | II | CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia. | VistaPharm, Inc. |
| Nov 9, 2016 | II | Microbial Contamination of Non-Sterile Products: bulk solution tested positive for the presence of the bacteria, Burkholderia cepacia. | VistaPharm, Inc. |
Class I = reasonable probability of serious harm · Class II = temporary or reversible · Class III = unlikely to cause harm.
Registration status
Some products from Actavis Pharma, Inc. are not FDA-registered for human use. For unregistered substances (peptides, SARMs without human registration), no legitimate human-use supplier exists. The absence of a sourcing route is the safety information.