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.
Reported: May 17, 2017 Initiated: April 28, 2017 #D-0698-2017
Product Description
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.
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.
Details
- Recalling Firm
- PAR Sterile Products LLC
- Units Affected
- 122,469 cartons
- Distribution
- Nationwide in the USA
- Location
- Rochester, MI
Frequently Asked Questions
What product 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.. Recalled by PAR Sterile Products LLC. Units affected: 122,469 cartons.
Why was this product 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 agency issued this recall? ▼
This recall was issued by the FDA Drug on May 17, 2017. Severity: Moderate. Recall number: D-0698-2017.
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