Neostigmine Methylsulfate (single dose syringe) 1 mg per mL 5 mg per 5 mL Injectable Hospital/Off...

FDA Drug Recall #D-0129-2018 — Class II — August 10, 2017

Recall Summary

Recall Number D-0129-2018
Classification Class II — Moderate risk
Date Initiated August 10, 2017
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Premier Pharmacy Labs Inc
Location Weeki Wachee, FL
Product Type Drugs
Quantity 1610 syringes

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.

Distribution Pattern

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

Other Recalls from Premier Pharmacy Labs Inc

Recall # Classification Product Date
D-1421-2019 Class II Naloxone HCL Preserved INJ, 500mg/50mL (10mg/mL... Jun 18, 2019
D-1415-2019 Class II Droperidol Injectable Sterile Solution, 0.625mg... Jun 18, 2019
D-1428-2019 Class II SUCCINYLcholine Chloride, 200mg/10mL (20mg/mL),... Jun 18, 2019
D-1412-2019 Class II Brilliant Blue Ophthalmic PF INJ, 0.5mg/mL (0.0... Jun 18, 2019
D-1422-2019 Class II Neostigmine Methylsulfate, 5mg/5mL (1mg/mL), 5m... Jun 18, 2019

Frequently Asked Questions

Stop using the medication immediately and contact your pharmacist. A mislabeling recall can range from a minor technical error (wrong font size) to a serious mix-up where one drug is inside another drug's packaging. If you received a medication that looks or acts differently than expected, or if you experienced unexpected effects, tell your doctor immediately. The pharmacist can verify whether your specific lot is affected and provide a replacement. Report any adverse effects experienced to FDA MedWatch at 1-800-FDA-1088.

Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.

Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.

What Should You Do?

Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.