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.
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.
Lot numbers, UPCs & expiration codes
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 it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0698-2017
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Apr 28, 2017
- FDA report date
- May 17, 2017
- Quantity
- 122,469 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- PAR Sterile Products LLC
Original FDA data
Every field from FDA enforcement report D-0698-2017, exactly as published.
Show all FDA fields
- City
- Rochester
- State
- MI
- Status
- Terminated
- Country
- United States
- Event ID
- 77169
- Address
- 870 Parkdale Rd
- Code information
- 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.
- Postal code
- 48307-1740
- Report date
- May 17, 2017
- Product type
- Drugs
- Recall number
- D-0698-2017
- Classification
- Class II
- Recalling firm
- PAR Sterile Products LLC
- Product quantity
- 122,469 cartons
- Termination date
- Mar 29, 2018
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Apr 28, 2017
- Initial firm notification
- Letter
- Center classification date
- May 9, 2017