Recalls / Class III
Class IIID-1585-2020
Product
Potassium Acetate Injection, USP 40 mEq/20 mL (2 mEq/mL) Single Dose Vials, Rx only, Manufactured By: Exela Pharma Sciences, LLC. Lenoir, NC NDC 51754-2001-4
- Affected lot / code info
- Lot #P0000471, Catalog #2020TS002, Exp Date: 04/2021
Why it was recalled
Short Fill
Recalling firm
- Firm
- Exela Pharma Sciences LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1245 Blowing Rock Blvd, N/A, Lenoir, North Carolina 28645-3618
Distribution
- Quantity
- 23,775 vials
- Distribution pattern
- Nationwide and Puerto Rico
Timeline
- Recall initiated
- 2020-05-05
- FDA classified
- 2020-09-14
- Posted by FDA
- 2020-09-23
- Terminated
- 2022-01-14
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1585-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.