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

FDA recall notice · announced December 27, 2017 · Premier Pharmacy Labs

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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

Reason for recall

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

Notes

Distribution: Michigan, Maryland, Minnesota, North Carolina, Ohio, Florida
Lot/code information: Lot # NEO071317MMDSA BUD: 01/19/2018 Lot # NEO071317MMDSC BUD: 01/19/2018 Lot # NEO071317MMDSF BUD: 01/19/2018
Quantity: 1610 syringes
Status: Terminated
Products in this recall event:
- 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, ND (D-0129-2018)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.