CLASS III Drug recall · Reported 6 Jan 2021 · FDA Enforcement Report
Neostigmine Methylsulfate PF Inj recalled by US Compounding
US Compounding is recalling Neostigmine Methylsulfate PF Inj, distributed nationwide in the US. The recall was initiated on 25 Nov 2020 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0175-2021
- FDA event ID
- 86929
- Recalling firm
- US Compounding, Conway, AR
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 25 Nov 2020
- FDA classified
- 29 Dec 2020
- Reported
- 6 Jan 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
- Drug class
- Compounded Drugs
Timeline
| 25 Nov 2020 | Recall initiated by company | |
| 29 Dec 2020 | Classified by FDA | +34 days |
| 6 Jan 2021 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labelling: Missing label.
Product as listed by the FDA
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
Where it was distributed
Nationwide
Questions about this recall
Is Neostigmine Methylsulfate PF Inj recalled?
Yes. US Compounding recalled Neostigmine Methylsulfate PF Inj on 25 Nov 2020. The recall is Class III and its status is Terminated. Recall number D-0175-2021.
Why was it recalled?
Labelling: Missing label.
Which lots are affected?
Lot: 20202109@3 BUD: 3/20/2021
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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|---|---|---|---|---|---|
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