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1 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride;...

FDA Drug Recall #D-1375-2016 — Class II — May 5, 2016

Recall Summary

Recall Number D-1375-2016
Classification Class II — Moderate risk
Date Initiated May 5, 2016
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Pharmedium Services, LLC
Location Lake Forest, IL
Product Type Drugs
Quantity 1,527 bags

Product Description

1 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; 150 mL in 150 mL Baxter Intravia Bag, Service Code 2K9998, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-998-95

Reason for Recall

Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.

Distribution Pattern

Nationwide

Lot / Code Information

Service Code 2K9998 , Lot Number 160460135M , Exp. Date 5/10/2016 ; Service Code 2K9998 , Lot Number 160530146M , Exp. Date 5/17/2016 ; Service Code 2K9998 , Lot Number 160590137M , Exp. Date 5/23/2016 ; Service Code 2K9998 , Lot Number 160660221M , Exp. Date 5/30/2016 ; Service Code 2K9998 , Lot Number 160730163M , Exp. Date 6/6/2016 ; Service Code 2K9998 , Lot Number 160870147M , Exp. Date 6/20/2016 ; Service Code 2K9998 , Lot Number 160880265M , Exp. Date 6/21/2016 ; Service Code 2K9998 , Lot Number 160940206M , Exp. Date 6/27/2016 ; Service Code 2K9998 , Lot Number 161080210M , Exp. Date 7/11/2016 ; Service Code 2T8998 , Lot Number 160460267M , Exp. Date 5/7/2016 ; Service Code 2T8998 , Lot Number 160470042M , Exp. Date 5/8/2016 ; Service Code 2T8998 , Lot Number 160530034M , Exp. Date 5/14/2016 ; Service Code 2T8998 , Lot Number 160610043M , Exp. Date 5/22/2016 ; Service Code 2T8998 , Lot Number 160640008M , Exp. Date 5/24/2016 ; Service Code 2T8998 , Lot Number 160690011C , Exp. Date 5/30/2016 ; Service Code 2T8998 , Lot Number 160690012C , Exp. Date 5/30/2016 ; Service Code 2T8998 , Lot Number 160740064C , Exp. Date 6/4/2016 ; Service Code 2T8998 , Lot Number 160810066C , Exp. Date 6/11/2016 ; Service Code 2T8998 , Lot Number 160840030C , Exp. Date 6/14/2016 ; Service Code 2T8998 , Lot Number 160880042C , Exp. Date 6/18/2016 ; Service Code 2T8998 , Lot Number 160880043C , Exp. Date 6/18/2016 ; Service Code 2T8998 , Lot Number 160910014C , Exp. Date 6/21/2016 ; Service Code 2T8998 , Lot Number 160910015C , Exp. Date 6/21/2016 ; Service Code 2T8998 , Lot Number 160950071C , Exp. Date 6/25/2016 ;

Other Recalls from Pharmedium Services, LLC

Recall # Classification Product Date
D-1087-2020 Class II rocuronium Bromide, 10 mg per mL, 50 mg per 5 m... Mar 16, 2020
D-1088-2020 Class II ePHEDrine Sulfate, 5 mg per mL, 25 mg per 5 mL ... Mar 16, 2020
D-1085-2020 Class II fentaNYL Citrate 10 mcg per mL, 2,500 mcg per 2... Mar 16, 2020
D-1082-2020 Class II nICARdipine HCl (0.1 mg/mL) 1 mg/10mL, in 0.9%... Mar 16, 2020
D-1083-2020 Class II rocuronium Bromide 10 mg per mL 50 mg per 5 mL,... Mar 16, 2020

Frequently Asked Questions

Injectable drugs and eye drops must be completely free of microbial contamination because they bypass the body's natural defenses. A contaminated injectable can introduce bacteria or fungi directly into the bloodstream, potentially causing sepsis, meningitis, or localized infections — all of which can be life-threatening. Contamination of sterile products almost always results in a Class I recall. If you received an injectable drug from a recalled lot, contact your healthcare provider immediately, even if you feel well, as some infections can have delayed onset.

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.

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