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
Reported: May 2, 2018 Initiated: April 11, 2018 #D-0700-2018
Product Description
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 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.
Details
- Recalling Firm
- Premier Pharmacy Labs Inc
- Units Affected
- 4192 syringes
- Distribution
- Nationwide in the USA
- Location
- Weeki Wachee, FL
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Premier Pharmacy Labs Inc. Units affected: 4192 syringes.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on May 2, 2018. Severity: Moderate. Recall number: D-0700-2018.
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