Premier Pharmacy Labs Recalls Neostigmine Methylsulfate Syringes Due to Labeling Error
Premier Pharmacy Labs is recalling Neostigmine Methylsulfate syringes because the printed beyond-use dates exceed current stability data.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a labeling error regarding stability dates, which fits the rubric criteria for minor labeling errors or low-risk contamination.
Plain-English summary
Premier Pharmacy Labs, Inc. is recalling 1,610 syringes of Neostigmine Methylsulfate (single dose syringe) 1 mg per mL 5 mg per 5 mL Injectable. The product is compounded for hospital and office use only. The recall involves three specific lots: NEO071317MMDSA, NEO071317MMDSC, and NEO071317MMDSF, all with a beyond-use date of 01/19/2018.
The recall was initiated due to a labeling error where the indicated beyond-use date exceeds current stability data. This means the expiration date printed on the product does not align with the available stability information for the compound.
The affected product was distributed to facilities in Michigan, Maryland, Minnesota, North Carolina, Ohio, and Florida. Healthcare providers and facilities should check their inventory for the specific lot numbers listed and discontinue use of the affected syringes.
The recalled product
- Product
- Neostigmine Methylsulfate (single dose syringe) 1 mg per mL 5 mg per 5 mL Injectable Hospital/Office Use Only Compounded by: Premier Pharmacy Labs., Inc. 8265 Commercial Way Weeki Wachee, FL 34613, NDC# 69623-234-15
- Manufacturer
- Premier Pharmacy Labs Inc
- Category
- Drug — Injectable
- Hazard
- Affected units
- 1,610
Distribution
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