PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: December 27, 2017 Initiated: August 10, 2017 #D-0129-2018

Product Description

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

Reason for Recall

Stability Date Doesn't Support Expiry: labeling error indicating a beyond use date that exceeds current stability data.

Details

Recalling Firm
Premier Pharmacy Labs Inc
Units Affected
1610 syringes
Distribution
Michigan, Maryland, Minnesota, North Carolina, Ohio, Florida
Location
Weeki Wachee, FL

Frequently Asked Questions

What product was recalled?
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. Recalled by Premier Pharmacy Labs Inc. Units affected: 1610 syringes.
Why was this product recalled?
Stability Date Doesn't Support Expiry: labeling error indicating a beyond use date that exceeds current stability data.
Which agency issued this recall?
This recall was issued by the FDA Drug on December 27, 2017. Severity: Moderate. Recall number: D-0129-2018.