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.
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
Lot numbers, UPCs & expiration codes
Lots: HYD030118IJDSA, HYD030118IJDSB, HYD030118IJDSD, HYD030118IJDSE BUD: 05/30/2018
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0701-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Apr 11, 2018
- FDA report date
- May 2, 2018
- Quantity
- 3570 syringes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Premier Pharmacy Labs Inc
Original FDA data
Every field from FDA enforcement report D-0701-2018, exactly as published.
Show all FDA fields
- City
- Weeki Wachee
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 79803
- Address
- 8265 Commercial Way
- Code information
- Lots: HYD030118IJDSA, HYD030118IJDSB, HYD030118IJDSD, HYD030118IJDSE BUD: 05/30/2018
- Postal code
- 34613-4511
- Report date
- May 2, 2018
- Product type
- Drugs
- Recall number
- D-0701-2018
- Classification
- Class II
- Recalling firm
- Premier Pharmacy Labs Inc
- Product quantity
- 3570 syringes
- Termination date
- Sep 15, 2020
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Apr 11, 2018
- Initial firm notification
- Press Release
- Center classification date
- Apr 26, 2018