CLASS II Drug recall · Reported 27 Dec 2017 · FDA Enforcement Report
Neostigmine Methylsulfate (single dose syringe) 1 mg per mL recalled
Premier Pharmacy Labs is recalling Neostigmine Methylsulfate (single dose syringe) 1 mg per mL 5 mg per Injectable, distributed in Florida, Maryland, Michigan, Minnesota, North Carolina, Ohio. The recall was initiated on 10 Aug 2017 and the FDA has classified it as Class II.
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-0129-2018
- FDA event ID
- 77979
- Recalling firm
- Premier Pharmacy Labs, Weeki Wachee, FL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 10 Aug 2017
- FDA classified
- 21 Dec 2017
- Reported
- 27 Dec 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
- Drug class
- Injectable & IV Drugs
Timeline
| 10 Aug 2017 | Recall initiated by company | |
| 21 Dec 2017 | Classified by FDA | +133 days |
| 27 Dec 2017 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Stability Date Doesn't Support Expiry: labeling error indicating a beyond use date that exceeds current stability data.
Product as listed by the FDA
Neostigmine Methylsulfate (single dose syringe) 1 mg per mL 5 mg per 5 mL Injectable Hospital/Office Use Only Compounded by: Premier Pharmacy Labs., Inc. 8265 Commercial Way Weeki Wachee, FL 34613, NDC# 69623-234-15
Where it was distributed
Michigan, Maryland, Minnesota, North Carolina, Ohio, Florida
Questions about this recall
Why was it recalled?
Stability Date Doesn't Support Expiry: labeling error indicating a beyond use date that exceeds current stability data.
Which lots are affected?
Lot # NEO071317MMDSA BUD: 01/19/2018 Lot # NEO071317MMDSC BUD: 01/19/2018 Lot # NEO071317MMDSF BUD: 01/19/2018
Where was it sold?
Michigan, Maryland, Minnesota, North Carolina, Ohio, Florida
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 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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