FDA Drug Recalls

Recalls / Class III

Class IIID-0175-2021

Product

Neostigmine Methylsulfate PF Inj. 5 mg/5 mL, 5 mL Single Use Syringes, Hospital/Office Use Only. US Compounding 1270 Don's Lane Conway, AR 72032 (800) 718-3588 NDC 62295-3324-05

Affected lot / code info
Lot: 20202109@3 BUD: 3/20/2021

Why it was recalled

Labelling: Missing label.

Recalling firm

Firm
US Compounding Inc
Notification channel
Letter
Type
Voluntary: Firm initiated
Address
1270 Dons Ln, N/A, Conway, Arkansas 72032-4753

Distribution

Quantity
1640 syringes
Distribution pattern
Nationwide

Timeline

Recall initiated
2020-11-25
FDA classified
2020-12-29
Posted by FDA
2021-01-06
Terminated
2021-11-05
Status
Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-0175-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.

Class III recall: drug · FDA Drug Recalls