D-0701-2018 Class II Terminated
FDA drug recall D-0701-2018 was initiated by Premier Pharmacy Labs Inc on Apr 11, 2018 and is designated Class II. 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… The recall status is terminated (terminated Sep 15, 2020). Affected quantity: 3570 syringes.
Recall Details
- Product Type
- Drugs
- Report Date
- May 2, 2018
- Initiation Date
- Apr 11, 2018
- Termination Date
- Sep 15, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3570 syringes
Product Description
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
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 Pattern
Nationwide in the USA
Code Information
Lots: HYD030118IJDSA, HYD030118IJDSB, HYD030118IJDSD, HYD030118IJDSE BUD: 05/30/2018
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0701-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026