Recalls / Class II
Class IID-0129-2018
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 lot / code info
- Lot # NEO071317MMDSA BUD: 01/19/2018 Lot # NEO071317MMDSC BUD: 01/19/2018 Lot # NEO071317MMDSF BUD: 01/19/2018
Why it was recalled
Stability Date Doesn't Support Expiry: labeling error indicating a beyond use date that exceeds current stability data.
Recalling firm
- Firm
- Premier Pharmacy Labs Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 8265 Commercial Way, Weeki Wachee, Florida 34613-4511
Distribution
- Quantity
- 1610 syringes
- Distribution pattern
- Michigan, Maryland, Minnesota, North Carolina, Ohio, Florida
Timeline
- Recall initiated
- 2017-08-10
- FDA classified
- 2017-12-21
- Posted by FDA
- 2017-12-27
- Terminated
- 2018-03-29
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0129-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.