Recalls / Class II
Class IID-0982-2023
Product
neostigmine 5 mg/5mL (1mg/mL) Syringe, Rx only, This drug was repacked by CAPS, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6065-1
- Affected lot / code info
- Lot: 36-239285, 36-239287, Exp. 7/11/2023; 36-239456, Exp. 7/12/2023; 36-239873, Exp. 7/13/2023; 36-240994, 36-240995, 36-240996, 36-240997, Exp. 7/18/2023; 36-241447, Exp. 7/20/2023, 36-242407, 36-242408, Exp. 7/25/2023; 36-246298, Exp. 8/3/2023; 36-248998, Exp. 8/16/2023; 36-251613, Exp. 8/28/2023; 36-251781, Exp. 8/29/2023.
Why it was recalled
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Recalling firm
- Firm
- Central Admixture Pharmacy Services, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2200 S 43rd Ave, N/A, Phoenix, Arizona 85043-3909
Distribution
- Quantity
- 6,468 Syringes
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2023-07-14
- FDA classified
- 2023-08-01
- Posted by FDA
- 2023-08-09
- Terminated
- 2025-03-28
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0982-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.