Generic drug makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of Endo InternationalLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 4 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Par Sterile Products with 4 drug recalls, 2 drug applications and 1 complete response letter. The most recent is a drug recall dated Nov 9, 2021: Buprenorphine HCl, Injection, 0.3mg/mL, For Intramuscular or Intravenous Use, Rx Only, 1….
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Nov 9, 2021 | Buprenorphine HCl, Injection, 0.3mg/mL, For Intramuscular or Intravenous Use, Rx Only, 1mL Single Dose Vial, (supplied in packages of 5 vialClass II · Crystallization; identified as Buprenorphine free base | Drug recalls |
| May 18, 2020 | Complete response letter, NDA 212156Approved | Complete response letters |
| Apr 28, 2017 | Buprenorphine HCI Injection, 0.3 mg/mL, 1 mL Single Dose Vial (NDC 42023-179-01), packaged in 1 mL x 5 Single Dose Vials per carton (NDC 420Class II · Crystallization: due to the presence of white, crystalline particulates, adhered to the side and bottom of the glass via | Drug recalls |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
