The Recall Desk
ModerateFDA (Drugs)·D-0129-2018·Announced 2017-12-27

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.

What this means for you

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
Affected units
1,610

Distribution

Distributed in 6 states: