Food, drugs, devices › Premier Pharmacy Labs Inc
Drug recall: Neostigmine Methylsulfate (single dose syringe) 1 mg per mL 5 mg per 5 mL Injectable Hospital/Office Use Only Compounded
Premier Pharmacy Labs Inc (Weeki Wachee, FL) initiated this drug recall on 10 Aug 2017; FDA lists 1 product record under event 77979, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 57% of the 343 drug enforcement events initiated in 2017 carry the same class.
Status: Terminated, terminated 29 Mar 2018. Initiation: voluntary: firm initiated. Premier Pharmacy Labs Inc has 4 enforcement events on this register, with a median of 4 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Premier Pharmacy Labs Inc, Weeki Wachee, FL.
Reason for recall
"Stability Date Doesn't Support Expiry: labeling error indicating a beyond use date that exceeds current stability data."
Distribution
"Michigan, Maryland, Minnesota, North Carolina, Ohio, Florida"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-0129-2018 | 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 | 1610 syringes | Class II | Terminated | 27 Dec 2017 |
Context
Other enforcement events for Premier Pharmacy Labs Inc
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 18 Jun 2019 | Atropine Sulfate PF INJ, 0.8 mg/2 mL (0.4 mg/mL), 2mL Single Dose Syringe, Rx only, Premier Pharmacy Labs, 8265 Commerci | Drug | Class II | 18 |
| 11 Apr 2018 | Morphine Sulfate 2 mg/mL PF Injection. 1 mL in a 3ml Sterile Single-Dose Syringe. 8265 Commerical Way Weeki Wachee, FL 3 | Drug | Class II | 4 |
| 11 Jan 2018 | Mitomycin 40 mg/mL Preservative Free Irrigation Volume: 10 mL SDV , Compounded by: Premier Pharmacy Labs 8265 Commercial | Drug | Class II | 1 |
All 4 events for Premier Pharmacy Labs Inc
Questions and answers
Why was this drug recalled?
FDA's record gives the reason for recall as: "Stability Date Doesn't Support Expiry: labeling error indicating a beyond use date that exceeds current stability data."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Michigan, Maryland, Minnesota, North Carolina, Ohio, Florida"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 29 Mar 2018. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.