Morphine Sulfate 4 mg/mL PF Injection recall: Sterility Concern
Morphine Sulfate 4 mg/mL PF Injection. 1 mL in a 3ml Sterile Single-Dose Syringe. 8265 Commerical Way Weeki Wachee, FL 34613. NDC 69623-127-10
Why was Morphine Sulfate 4 mg/mL PF Injection 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lots: MOR022318NWDSA, MOR022318NWDSB, MOR022318NWDSC, MOR022318NWDSD, MOR022318NWDSE BUD: 05/24/2018
- Product
- Morphine Sulfate 4 mg/mL PF Injection. 1 mL in a 3ml Sterile Single-Dose Syringe. 8265 Commerical Way Weeki Wachee, FL 34613. NDC 69623-127-10
- Recalling firm
- Premier Pharmacy Labs Inc
- Quantity
- 4192 syringes
- Distribution
- Nationwide in the USA
- Recall date
- May 2, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)