Recalls / Class II
Class IID-0698-2017
Product
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.
- Brand name
- Buprenorphine Hydrochloride
- Generic name
- Buprenorphine Hydrochloride
- Active ingredient
- Buprenorphine Hydrochloride
- Route
- Intramuscular, Intravenous
- NDC
- 42023-179
- FDA application
- ANDA206586
- Affected lot / code info
- 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.
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.
Recalling firm
- Firm
- PAR Sterile Products LLC
- Manufacturer
- Par Health USA, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 870 Parkdale Rd, N/A, Rochester, Michigan 48307-1740
Distribution
- Quantity
- 122,469 cartons
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2017-04-28
- FDA classified
- 2017-05-09
- Posted by FDA
- 2017-05-17
- Terminated
- 2018-03-29
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0698-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.