Recalls / Class II
Class IID-0701-2018
Product
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
- Affected lot / code info
- Lots: HYD030118IJDSA, HYD030118IJDSB, HYD030118IJDSD, HYD030118IJDSE BUD: 05/30/2018
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.
Recalling firm
- Firm
- Premier Pharmacy Labs Inc
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 8265 Commercial Way, N/A, Weeki Wachee, Florida 34613-4511
Distribution
- Quantity
- 3570 syringes
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2018-04-11
- FDA classified
- 2018-04-26
- Posted by FDA
- 2018-05-02
- Terminated
- 2020-09-15
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0701-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.