Class III · Low risk
Buprenorphine Sublingual Tablets
Labeling: Label Mix-up
Buprenorphine HCI Injection (Buprenorphine Hydrochloride)
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was 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.
Cause type: Failed specification
A physical or chemical test other than potency, dissolution, impurity or stability failed - pH, viscosity, appearance, tablet integrity, fill volume. A product outside its own specification may not perform as designed, even if the active ingredient is present. All failed specification recalls.
What was recalled
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.
Affected NDCs
42023-0179-01
42023-0179-05
Compare with the code on your package — it is the most precise check available.
Drug: Buprenorphine
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Buprenorphine Hydrochloride NDC 42023-0179 |
.324 mg/mL | Injection Intramuscular|intravenous |
Par Health USA, LLC | Rx · CIII |
- Recalling firm
- PAR Sterile Products LLC
- NDC code
- 42023-179-01
- Origin
- MI, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0698-2017 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Buprenorphine recalls
See all
Class II · Moderate risk
Buprenorphine HCl
Crystallization; identified as Buprenorphine free base
Class II · Moderate risk
Buprenorphine Hydrochloride
Crystallization; identified as Buprenorphine free base
Class II · Moderate risk
Buprenorphine Hydrochloride Injection
Lack of Assurance of Sterility-The potential for incomplete crimp seals.
Class II · Moderate risk
Buprenorphine Sublingual Tablets
CGMP Deviations
Other recalls by PAR Sterile Products LLC
All 2017 recalls
Class I · High risk
Treprostinil Injection
Presence of Particulate Matter.
Class II · Moderate risk
Vasostrict
Superpotent Drug: Assay from the 3-month and 6-month stability intervals exceeded the upper specification limit.
Class II · Moderate risk
Buprenorphine HCl
Crystallization; identified as Buprenorphine free base
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