Recalls / Class II
Class IID-0315-2022
Product
dilTIAZem HCl in 5% Dextrose Injection, 125 mg per 125 mL, (32 mcg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-951-01.
- Affected lot / code info
- S21200/BVC 15-Nov-21 S21296/BYM 19-Dec-21 S21320/BZG 4-Jan-22 S21164/BTV 3-Dec-21 S21191/BUU 18-Dec-21 S21197/BUZ 31-Dec-21 S21220/BVV 13-Jan-22 S21271/BXO 27-Jan-22 S21272/BXP 28-Jan-22 S21299/BYP 18-Feb-22 S21300/BYQ 19-Feb-22
Why it was recalled
Lack of Assurance of Sterility
Recalling firm
- Firm
- SterRx, LLC
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 141 Idaho Ave, Plattsburgh, New York 12903-3987
Distribution
- Quantity
- 8946 bags
- Distribution pattern
- U.S.A. Nationwide
Timeline
- Recall initiated
- 2021-11-12
- FDA classified
- 2021-12-29
- Posted by FDA
- 2022-01-05
- Terminated
- 2023-12-06
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0315-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.