FDA Drug recall 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
- FDA Drug
- Class II
- terminated
- Published 2018-05-02
On 2018-05-02 the FDA classified a Class II recall of Morphine Sulfate 4 mg/mL PF Injection. 1 mL in a 3ml Sterile Single-Dose Syringe. 8265 Commerical Way Weeki Wachee, FL 34613 by Premier Pharmacy Labs, citing 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….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0700-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-04-11 |
| Published | 2018-05-02 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Premier Pharmacy Labs |
| Distribution | US |
Product
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
Reason
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.
Identifiers
| code_info | Lots: MOR022318NWDSA, MOR022318NWDSB, MOR022318NWDSC, MOR022318NWDSD, MOR022318NWDSE BUD: 05/24/2018 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0700-2018%22
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