Key Takeaway

Parenteral Amino Acid Infusion 10%, Packaged in a) 780ML Homepumps, b) 1000ML Homepumps, c) 1140ML Homepumps, d) 1152ML Homepumps, e) 1400ML Homepumps, f) 1440ML Homepumps, g) 1500ML Homepumps, h) 170 by Sentara Enterprises was recalled on September 18, 2015. The hazard: Lack of Assurance of Sterility: Product sterility cannot be guaranteed.

FDA Drug Class II Terminated

Parenteral Amino Acid Infusion 10%, Packaged in a) 780ML Homepumps, b) 1000ML Homepumps, c) 1140ML Homepumps, d) 1152ML Homepumps, e) 1400ML Homepumps, f) 1440ML Homepumps, g) 1500ML Homepumps, h) 170

Recalled: September 18, 2015 ~a) 7, b) 7, c) 6, d) 7, e) 4, f) 13, g) 2, h) 4, i) 7, j) 5, k) 10, l) 11, m) 11, n) 11, o) 7, p) 7, q) 7 Bags units affected D-0614-2016

Description

Parenteral Amino Acid Infusion 10%, Packaged in a) 780ML Homepumps, b) 1000ML Homepumps, c) 1140ML Homepumps, d) 1152ML Homepumps, e) 1400ML Homepumps, f) 1440ML Homepumps, g) 1500ML Homepumps, h) 1700ML Homepumps, i) 1900ML Homepumps, j) 2130ML Homepumps, k) 2250ML Homepumps, l) 2400ML Homepumps, m) 2650ML Homepumps, n) 2700ML Homepumps, o) 3250ML Homepumps, p) 3390ML Homepumps, and q) 3500ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.

Hazard / Reason

Lack of Assurance of Sterility: Product sterility cannot be guaranteed.

Class II: Product that may cause temporary or medically reversible health consequences.

Class II indicates the product may cause temporary or medically reversible health effects. The probability of serious harm is considered remote.

Products Affected

Parenteral Amino Acid Infusion 10%, Packaged in a) 780ML Homepumps, b) 1000ML Homepumps, c) 1140ML Homepumps, d) 1152ML Homepumps, e) 1400ML Homepumps, f) 1440ML Homepumps, g) 1500ML Homepumps, h) 170

Drugs

Company Information

Sentara Enterprises

Chesapeake, VA, United States

View all 34 recalls by Sentara Enterprises →

Distribution

U.S. Including: VA, NC

Related Recalls

FDA Drug Class II

Lactated Ringers, Packaged in a) 1500ML Homepumps, b) 2800ML Homepumps, and c) 3600ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.

September 18, 2015
FDA Drug Class II

PENICILLIN in D5W, Packaged as a)36MU in 360ML Homepumps and b) 51MU in 510ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.

September 18, 2015
FDA Drug Class II

Tobramycin 120MG, Packaged in 150ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.

September 18, 2015
FDA Drug Class II

Cancidas (caspofungin acetate) 58.4MG in NS, Packaged in 116.8ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.

September 18, 2015
FDA Drug Class II

HYDROMORPHONE HCL, Packaged as a) 2.5MG in 1ML Syringes, b) 150MG in 75ML Homepumps, c) 125MG in 125ML Homepumps, d) 250MG in 125ML Homepumps, e) 135MG in 135ML Homepumps, Rx Only. SENTARA HOME HEALT

September 18, 2015
FDA Drug Class II

Dextrose-NaCl (D5-1/2NS) in NS, Packaged in a) 1700ML Homepumps, b) 1800ML Homepumps, and c) 1920ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 2

September 18, 2015

Frequently Asked Questions

Is this recall still active?

Check the status badge at the top of this page. "Ongoing" means the recall is still active and you should follow the remedy instructions. "Completed" or "Terminated" means the recall process has concluded, though the safety issue remains relevant for any unrepaired products.

How do I check if my product is affected?

Compare the model number, lot code, serial number, or date range listed in the recall notice with the information on your product's label or packaging. For vehicles, check your VIN at NHTSA.gov/Recalls.

What remedy is available for this recall?

Check the remedy section above or contact the manufacturer directly for current remedy options.

Where can I find the original recall notice?

This recall was issued by FDA Drug. Visit the agency's official website for the original notice.

Data sourced from FDA Drug Enforcement. Recall information may not reflect the most current status. RecallDex is not affiliated with any US government agency. Contact the manufacturer or relevant agency for the latest information.