Premier Pharmacy Labs Recalls Morphine Sulfate Syringes Due to Sterility Concerns
Premier Pharmacy Labs Inc is recalling 4,192 syringes of Morphine Sulfate 4 mg/mL PF Injection due to a lack of assurance of sterility.
What this means for you
Illness, injury, or structural failure has been reported. 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. According to the rubric, an FDA Class II recall involving a risk of serious health consequences (microbial contamination of a sterile injectable drug) corresponds to a severity score of 4 (Severe).
Plain-English summary
Premier Pharmacy Labs Inc is recalling 4,192 syringes of Morphine Sulfate 4 mg/mL PF Injection, 1 mL in a 3ml Sterile Single-Dose Syringe. The affected product is identified by NDC 69623-127-10 and includes lots MOR022318NWDSA, MOR022318NWDSB, MOR022318NWDSC, MOR022318NWDSD, and MOR022318NWDSE, all with a best-use-by date of 05/24/2018.
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.
The affected syringes were distributed nationwide in the USA. Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- 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
- Manufacturer
- Premier Pharmacy Labs Inc
- Category
- Drug — Injectable
- Affected units
- 4,192
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: MOR022318NWDSA
- MOR022318NWDSB
- MOR022318NWDSC
- MOR022318NWDSD
- MOR022318NWDSE BUD: 05/24/2018
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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