Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Hydromorphone HCl 1 mg/mL PF INJ. 1mL in a 3mL Recalled by Premier Pharmacy Labs Inc Due to Lack of Assurance of Sterility:Microbial contamination was detected...

Date: April 11, 2018
Company: Premier Pharmacy Labs Inc
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Premier Pharmacy Labs Inc directly.

Affected Products

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

Quantity: 3570 syringes

Why Was This 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.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Premier Pharmacy Labs Inc

Premier Pharmacy Labs Inc has 24 total recalls tracked by RecallDetector.

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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report