Premier Pharmacy Labs Recalls Morphine Sulfate Injection Due to Sterility Concerns
Premier Pharmacy Labs is recalling specific lots of Morphine Sulfate Injection because routine testing of other lots detected microbial contamination risks.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves potential microbial contamination of a sterile injectable drug, which poses a significant risk of serious injury or infection.
Plain-English summary
Premier Pharmacy Labs Inc is recalling 4,555 syringes of Morphine Sulfate 2 mg/mL PF Injection. The affected product is distributed nationwide in the USA and is identified by NDC 69623-129-10. The specific lots involved are MOR030518IJDSA, MOR030518IJDSB, MOR030518IJDSC, MOR030518IJDSD, and MOR030518IJDSE, all with a beyond-use date of 06/03/2018.
The recall was initiated due to a lack of assurance of sterility. Microbial contamination was detected during routine testing of subsequent unreleased product lots. This issue was attributed to an interaction between the product syringe and the tamper-evident container closure, which may result in the potential introduction of microorganisms into the products.
Consumers and healthcare providers should check their inventory for the specific lot numbers and beyond-use date listed above. If the product matches these details, it should be discontinued and returned to the supplier or disposed of according to local regulations.
The recalled product
- Product
- Morphine Sulfate 2 mg/mL PF Injection. 1 mL in a 3ml Sterile Single-Dose Syringe. 8265 Commerical Way Weeki Wachee, FL 34613. NDC 69623-129-10
- Manufacturer
- Premier Pharmacy Labs Inc
- Category
- Drug — Injectable
- Affected units
- 4,555
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Lots: MOR030518IJDSA
- MOR030518IJDSB
- MOR030518IJDSC
- MOR030518IJDSD
- MOR030518IJDSE BUD: 06/03/2018
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Premier Pharmacy Labs Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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