CLASS II Drug recall · Reported 17 May 2017 · FDA Enforcement Report
Buprenorphine HCI Injection, 0.3 mg/mL Single Dose Vial recalled
PAR Sterile Products is recalling Buprenorphine HCI Injection, 0.3 mg/mL Single Dose Vial (, distributed nationwide in the US. The recall was initiated on 28 Apr 2017 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0698-2017
- FDA event ID
- 77169
- Recalling firm
- PAR Sterile Products, Rochester, MI
- Manufacturer
- Par Health USA, LLC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 28 Apr 2017
- FDA classified
- 9 May 2017
- Reported
- 17 May 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Drug class
- Injectable & IV Drugs
Timeline
| 28 Apr 2017 | Recall initiated by company | |
| 9 May 2017 | Classified by FDA | +11 days |
| 17 May 2017 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Product as listed by the FDA
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 42023-179-05), Rx Only, Distributed by: Par Pharmaceuticals Companies, Inc., Spring Valley, NY 10977.
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Lot #: 821102, 821103, Exp 01/18; 821104, 821106, 821107, Exp 02/18; 821108, Exp 03/18; 821884, 821885, Exp 07/18; 821886, 821887, Exp 08/18; 822767, Exp 09/18; 824183, Exp 10/18.
Where was it sold?
Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from PAR Sterile Products
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Treprostinil Injection, 20 mg/ (1 mg/mL) recalled | Par Sterile Products | Particulate Matter | Nationwide |
| Drug | CLASS II | Vasostrict (vasopressin in 5% Dextrose) Injection per mL) recalledVasostrict | Par Sterile Products | Potency & Assay | Nationwide |
| Drug | CLASS II | Buprenorphine HCl, Injection, 0.3mg/mL recalled by PAR Sterile ProductsBuprenorphine Hydrochloride | PAR Sterile Products | Packaging Defects | Nationwide |
Other Buprenorphine recalls
All 23| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Buprenorphine Hydrochloride, Injection 0.3 mg/mL recalledBuprenorphine Hydrochloride | Par Health USA | Other | Nationwide |
| Drug | CLASS III | Buprenorphine Sublingual Tablets (C-iii), 2 mg recalledBuprenorphine | American Health Packaging | Packaging Defects | Nationwide |
| Drug | CLASS II | Buprenorphine HCl, CIII, Injection, 0.3 mg/mL recalled by Par Health USABuprenorphine Hydrochloride | Par Health USA | Other | Nationwide |
| Drug | CLASS II | Buprenorphine Hydrochloride, Injection, 0.3mg/mL recalled by Endo UsaBuprenorphine Hydrochloride | Endo USA | Other | Nationwide |
| Drug | CLASS II | Buprenorphine Hydrochloride Injection recalled by PfizerBuprenorphine Hydrochloride | Pfizer | Sterility | Nationwide |