Manufacturer profile
Clinical Solutions Wholesale, LLC
Pharmaceutical company2 products tracked
2
products tracked
125,251
total reports
30
recalls on record
51.6%
serious overall
Products
showing 2 of 2
| Product | Approved | Reports ↓ | Top signal | Recalls |
|---|---|---|---|---|
| 1996 | 123,005 | Inadequate analgesia | 30 | |
| — | 2,246 | Product solubility abnormal | 0 |
Recall history · 30 on record
| Date | Class | Reason | Firm |
|---|---|---|---|
| Jun 12, 2026 | II | Crystallization; identified as Buprenorphine free base | Par Health USA, LLC |
| Mar 13, 2026 | II | Crystallization; identified as Buprenorphine free base | ENDO USA, Inc. |
| May 20, 2024 | II | Lack of Assurance of Sterility-The potential for incomplete crimp seals. | Pfizer Inc. |
| May 3, 2023 | II | CGMP Deviations | SUN PHARMACEUTICAL INDUSTRIES INC |
| Feb 15, 2023 | III | Failed Impurities/Degradation Specifications: Out of specification for related substance 10-hydroxy buprenorphine N-Oxide results generated at the 18-month stability timepoint. | AVEVA Drug Delivery Systems, Inc. |
| Feb 15, 2023 | III | Failed Impurities/Degradation Specifications: Out of specification for related substance 10-hydroxy buprenorphine N-Oxide results generated at the 18-month stability timepoint. | AVEVA Drug Delivery Systems, Inc. |
| Dec 22, 2022 | II | Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. | Pharmacy Innovations |
| Oct 18, 2022 | II | Presence of Foreign Substance | SUN PHARMACEUTICAL INDUSTRIES INC |
| Nov 9, 2021 | II | Crystallization; identified as Buprenorphine free base | PAR Sterile Products LLC |
| Mar 15, 2021 | II | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. |
| Mar 15, 2021 | II | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. |
| Mar 15, 2021 | II | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. |
| Feb 26, 2021 | II | Subpotent drug: Out of specification for assay of naloxone and buprenorphine (low) | Alvogen, Inc |
| Sep 4, 2020 | II | Failed Stability Specifications: Below specification result for buprenorphine release rate. | Teva Pharmaceuticals USA |
| Aug 14, 2020 | II | Sub-potent Drug: Out-of-Specification assay results found at 3 month stability testing. | Hikma Pharmaceuticals USA Inc. |
| Mar 10, 2020 | II | Subpotent Drug | Matthew 7:25 Inc dba Thrive Pharmacy |
| Mar 10, 2020 | II | Subpotent Drug | Matthew 7:25 Inc dba Thrive Pharmacy |
| Jun 29, 2017 | III | Failed Impurities/Degradation Specifications: out of specification test results for related compounds largest unknown impurity. | Teva Pharmaceuticals USA |
| Jun 29, 2017 | III | Failed Impurities/Degradation Specifications: out of specification test results for related compounds largest unknown impurity. | Teva Pharmaceuticals USA |
| Apr 28, 2017 | II | Crystallization: due to the presence of white, crystalline particulates, adhered to the side and bottom of the glass vials, which are comprised of principally dextrose and the buprenorphine active component. | PAR Sterile Products LLC |
| Feb 7, 2017 | II | Failed Impurities/Degradation Specifications | Teva Pharmaceuticals USA |
| Jul 26, 2016 | II | Lack of Assurance of Sterility | Pharmacy Plus, Inc. dba Vital Care Compounder |
| Sep 9, 2014 | II | Failed Impurities/Degradation Specification: Out of Specification results for pseudobuprenorphine impurity at the 9-month stability time point. | Hospira Inc. |
| Apr 7, 2014 | II | Failed Impurities/Degradation Specifications: High out of specification impurity test results were obtained during stability testing. | Teva Pharmaceuticals USA |
| Apr 7, 2014 | II | Failed Impurities/Degradation Specifications: High out of specification impurity test results were obtained during stability testing. | Teva Pharmaceuticals USA |
| Jul 26, 2013 | II | Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance | Beacon Hill Medical Pharmacy, P.C. |
| Jul 2, 2013 | II | Labeling: Label Mixup: BUPRENORPHINE HCL SL, Tablet, 2 mg may be potentially mislabeled as one of the following drugs: DOCUSATE SODIUM, Capsule, 250 mg, NDC 00904789159, Pedigree: AD37072_4, EXP: 5/13/2014; MAGNESIUM CHLORIDE DR, Tablet, 64 mg, NDC 00904791152, Pedigree: AD54510_1, EXP: 2/28/2014. | Aidapak Services, LLC |
| May 29, 2013 | II | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes | Lowlite Investments, Inc. D/B/A Olympia Pharmacy |
| Apr 10, 2013 | II | Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. | FVS Holdings, Inc. dba. Green Valley Drugs |
| Mar 25, 2013 | II | Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance | Pallimed Solutions |
Class I = reasonable probability of serious harm · Class II = temporary or reversible · Class III = unlikely to cause harm.
Registration status
Some products from Clinical Solutions Wholesale, LLC 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.