Why it was recalled
Stability Date Doesn't Support Expiry: labeling error indicating a beyond use date that exceeds current stability data.
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
Lot numbers, UPCs & expiration codes
Lot # NEO071317MMDSA BUD: 01/19/2018 Lot # NEO071317MMDSC BUD: 01/19/2018 Lot # NEO071317MMDSF BUD: 01/19/2018
Where it was sold
Michigan, Maryland, Minnesota, North Carolina, Ohio, Florida
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0129-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 10, 2017
- FDA report date
- Dec 27, 2017
- Quantity
- 1610 syringes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Premier Pharmacy Labs Inc
Original FDA data
Every field from FDA enforcement report D-0129-2018, exactly as published.
Show all FDA fields
- City
- Weeki Wachee
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 77979
- Address
- 8265 Commercial Way
- Code information
- Lot # NEO071317MMDSA BUD: 01/19/2018 Lot # NEO071317MMDSC BUD: 01/19/2018 Lot # NEO071317MMDSF BUD: 01/19/2018
- Postal code
- 34613-4511
- Report date
- Dec 27, 2017
- Product type
- Drugs
- Recall number
- D-0129-2018
- Classification
- Class II
- Recalling firm
- Premier Pharmacy Labs Inc
- Product quantity
- 1610 syringes
- Termination date
- Mar 29, 2018
- Reason for recall
- Stability Date Doesn't Support Expiry: labeling error indicating a beyond use date that exceeds current stability data.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Michigan, Maryland, Minnesota, North Carolina, Ohio, Florida
- Recall initiation date
- Aug 10, 2017
- Initial firm notification
- Letter
- Center classification date
- Dec 21, 2017