Buprenorphine Hydrochloride, Injection 0.3 mg/mL, Rx Only, 5 x 1 mL Single Dose Vials, Manufactured for: Endo USA, Malvern, PA, NDC 42023-1…
Par Health USA, LLC · Crystallization
- Status
- Ongoing
- City
- Rochester
- State
- MI
- Country
- United States
- Classification
- Class II
- Product type
- Drugs
- Event ID
- 99902
- Recalling firm
- Par Health USA, LLC
- Address 1
- 870 Parkdale Rd
- Postal code
- 48307-1740
- Voluntary mandated
- Voluntary: Firm initiated
- Initial firm notification
- Letter
- Distribution pattern
- U.S. Nationwide
- Recall number
- D-0876-2026
- Product description
- Buprenorphine Hydrochloride, Injection 0.3 mg/mL, Rx Only, 5 x 1 mL Single Dose Vials, Manufactured for: Endo USA, Malvern, PA, NDC 42023-179-05
- Product quantity
- 154210 bottles
- Reason for recall
- Crystallization
- Recall initiation date
- 20260908
- Center classification date
- 20260929
- Report date
- 20261007
- Code info
Lot#:83912, Exp Date 10/2026 Lot#:84234, Exp Date 11/2026 Lot#:84990, Exp Date 11/2026 Lot#:85003, Exp Date 12/2026 Lot#:86443, Exp Date 01/2027 Lot#:89909, Exp Date 05/2027
- Harmonized identifiers (openFDA)
- Application number
- ANDA206586
- Brand name
- BUPRENORPHINE HYDROCHLORIDE
- Generic name
- BUPRENORPHINE HYDROCHLORIDE
- Manufacturer name
- Par Health USA, LLC
- Product NDC
- 42023-179
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- INTRAMUSCULAR, INTRAVENOUS
- Substance name
- BUPRENORPHINE HYDROCHLORIDE
- RxCUI
- 238129
- SPL ID
- 32a7af7e-3f90-4881-9075-473644237017
- SPL set ID
- 34767dda-ce52-4f98-a45f-bb5cee0cd5e6
- Package NDC
- 42023-179-05
- Is original packager
- true
- UNII
- 56W8MW3EN1