Reported May 2, 2018 · Terminated
Hydromorphone HCl 1 mg/mL PF INJ. 1mL in a 3mL Sterile Single-Dose Syringe. 8265 Commercial Way Weeki Wachee, FL 34613…
Premier Pharmacy Labs Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Premier Pharmacy Labs Inc · 8265 Commercial Way · Weeki Wachee, FL · 34613-4511
Is this the product you have?
- 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
- Lot codes and dates
- Lots
HYD030118IJDSAHYD030118IJDSBHYD030118IJDSD
- HYD030118IJDSE BUD05/30/2018
- Lots
- Amount recalled
- 3570 syringes
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
- Nationwide
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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