FDARecall 100072Medicines
What to do
The FDA record of this recall has no instruction for consumers. Compare the lot codes below with your product. If they match, do not use it, and follow the notice of the firm or ask the store where you bought it. Talk to your pharmacist or doctor before stopping a medicine.Note from Recalls Watch, not agency text.
Read the official notice on accessdata.fda.gov (opens in a new tab)
Hazard
Why it was recalled
Particulate matter: particulate matter identified as cellulose, polystyrene, polyethylene teraphalate, stainless steel, or stopper material in the product solution.
FDA classification: Class I. FDA’s highest class: a reasonable probability that using the product will cause serious health consequences or death. Status: Ongoing.
Is it yours? Products and codes
Type the lot, batch, date code, model number or UPC printed on the product. It is compared here, in your browser, with the codes this notice lists. The code is also added to the page address (?lot=…), so a copied link or result carries it.
General information on recalls from the agency: U.S. Food and Drug Administration (opens in a new tab).
Argatroban Injection, USP, 250 mg/2.5mL (100 mg/mL), 2.5 mL x 1 Single Dose Vial, Rx only, Manufactured for: Endo USA, Malvern,PA 19355/Argatroban Injection, 250 mg/2.5mL (100 mg/mL), 2.5 mL x 1 Single Dose Vial, Rx only, Distributed by: Par Pharmaceutical, Chestnut Ridge, NY 10977, NDC 42023-182-01.
- Lot or code
- Lot #: 83449, Exp Date: 10/2026; 82682, Exp Date: 11/2026; 86714, 87302, 87560, Exp Date: 02/2027; 87753, 88401, Exp Date: 03/2027; 88614, 88836, Exp Date: 04/2027; 90220, Exp Date: 05/2027; 91216, 91219, Exp Date: 06/2027; 92004, 92006, Exp Date: 07/2027; 92009, 92596, 92782, 93107, 93329, Exp Date: 08/2027; 93890, Exp Date: 09/2027.
- FDA recall number
- D-0082-2027
- Quantity
- 18,991 vials
Argatroban Injection, USP, 250 mg/2.5mL (100 mg/mL), 2.5 mL x 1 Single Dose Vial, Rx only, Manufactured for: Endo USA, Malvern,PA 19355/ Argatroban Injection, 250 mg/2.5mL (100 mg/mL), 2.5 mL x 1 Single Dose Vial, Rx only, Distributed by: Par Pharmaceutical, Cranbury, NJ 08512, NDC 42023-182-89.
- Lot or code
- Lot #: 84193, Exp Date: 10/2026; 92880, Exp Date: 08/2027.
- FDA recall number
- D-0083-2027
- Quantity
- 1944 vials
Distribution (FDA): Nationwide within the United States
About this record
- Issued by
- U.S. Food and Drug Administration
- Firm
- Par Health USA, LLC (other notices of this firm)
- Title
- Composed by Recalls Watch from fields of the record; FDA records have no title.