Food, drugs, devices › Premier Pharmacy Labs Inc
Drug recall: Morphine Sulfate 2 mg/mL PF Injection. 1 mL in a 3ml Sterile Single-Dose Syringe. 8265 Commerical Way Weeki Wachee, FL 3
Premier Pharmacy Labs Inc (Weeki Wachee, FL) initiated this drug recall on 11 Apr 2018; FDA lists 4 product records under event 79803, 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. 60% of the 367 drug enforcement events initiated in 2018 carry the same class.
Status: Terminated, terminated 15 Sep 2020. 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
"Lack of Assurance of Sterility:Microbial contamination was detected during routine testing of subsequent unreleased product lots due to interaction between the product syringe and tamper evident container closure, which may result in the potential introduction of microorganisms into the products."
Distribution
"Nationwide in the USA"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-0699-2018 | Morphine Sulfate 2 mg/mL PF Injection. 1 mL in a 3ml Sterile Single-Dose Syringe. 8265 Commerical Way Weeki Wachee, FL 34613. NDC 69623-129-10 | 4555 syringes | Class II | Terminated | 2 May 2018 |
| D-0700-2018 | Morphine Sulfate 4 mg/mL PF Injection. 1 mL in a 3ml Sterile Single-Dose Syringe. 8265 Commerical Way Weeki Wachee, FL 34613. NDC 69623-127-10 | 4192 syringes | Class II | Terminated | 2 May 2018 |
| D-0701-2018 | Hydromorphone HCl 1 mg/mL PF INJ. 1mL in a 3mL Sterile Single-Dose Syringe. 8265 Commercial Way Weeki Wachee, FL 34613 NDC 69623-249-10 | 3570 syringes | Class II | Terminated | 2 May 2018 |
| D-0702-2018 | NEOstigmine Methylsulfate (1 mg/mL) 3mg per 3mL. 3mL Single Dose Syringe. Premier Pharmacy Labs. 8265 Commercial Way Weeki Wachee, FL 34613 NDC 69623-234-14. | 600 syringes | Class II | Terminated | 2 May 2018 |
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 Jan 2018 | Mitomycin 40 mg/mL Preservative Free Irrigation Volume: 10 mL SDV , Compounded by: Premier Pharmacy Labs 8265 Commercial | Drug | Class II | 1 |
| 10 Aug 2017 | Neostigmine Methylsulfate (single dose syringe) 1 mg per mL 5 mg per 5 mL Injectable Hospital/Office Use Only Compounded | 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: "Lack of Assurance of Sterility:Microbial contamination was detected during routine testing of subsequent unreleased product lots due to interaction between the product syringe and tamper evident container closure, which may result in the potential introduction of microorganisms into the products."
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: "Nationwide in the USA"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 15 Sep 2020. "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.