FDA event 72746 · Recall Observatory

drug · product 1 of 34

MEROPENEM in NS, Packaged as a) 1000MG in 250ML Homepumps, and b) 2GM in 100ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.

D-0611-2016

Recall number: D-0611-2016
Initiated: September 18, 2015
Classification: Class II
Status: Terminated
Recalling firm: Sentara Enterprises
Quantity: a) 159 Bags b) 33 Bags

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiries: a) 18-Sep-15, 20-Sep-15, 21-Sep-15, 22-Sep-15, 23-Sep-15, 24-Sep-15 b) 16-Sep-15, 19-Sep-15, 21-Sep-15

Distribution pattern

U.S. Including: VA, NC

drug · product 2 of 34

CUBICIN (daptomycin) in NS, Packaged as a) 350MG in 7ML Syringes, b)365MG in 7.3ML Syringes, c) 380MG in 7.6ML Syringes, d) 400MG in 8ML Syringes, e) 460MG in 9.2ML Syringes, f) 475MG in 9.5ML Syringes, g) 500MG in 10ML Syringes, h) 580MG in 116ML Homepumps, i) 600MG in 120ML Homepumps, j) 650MG in 13ML Syringes, k) 800MG in 40ML Homepumps, l) 950MG in 19 mL Syringes, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.

D-0612-2016

Recall number: D-0612-2016
Initiated: September 18, 2015
Classification: Class II
Status: Terminated
Recalling firm: Sentara Enterprises
Quantity: a) 7 Syr, b) 11 Syr, c) 5 Syr, d) 8 Syr, e) 6 Syr, f) 9 Syr, g) 4 Syr, h) 7 Bags, i) 7 Bags, j) 6 Syr, k) 3 Bags l) 4 Syr

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiries: a) 24-Sep-15, b) 24-Sep-15, 27-Sep-15, c) 26-Sep-15, d) 24-Sep-15, e) 27-Sep-15, f) 26-Sep-15, 27-Sept-15, g) 24-Sep-15, h) 26-Sep-15, i) 27-Sep-15, j) 26-Sep-15, k) 21-Sep-15 l) 24-Sep-15

Distribution pattern

U.S. Including: VA, NC

drug · product 3 of 34

SOD CHLORIDE (Sodium Chloride), Packaged in a) 0.9% in 30ML Homepumps, b) 0.9% 218ML Homepumps, c) 0.45% in 500ML Homepumps, d) 0.9% in 500ML Homepumps, e) 0.9% in 1500ML Homepumps, f) 0.45% in 1920ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.

D-0613-2016

Recall number: D-0613-2016
Initiated: September 18, 2015
Classification: Class II
Status: Terminated
Recalling firm: Sentara Enterprises
Quantity: a) 2 Bags, b) 1 Bags, c) 2 Bags, d) 4 Bags, e) 7 Bags f) 3 Bags

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiries: a) 28-Sep-15, 1-Oct-15, b) 22-Sep-15, c) 30-Sep-15 d) 29-Sep-15, e) 25-Sep-15, f) 28-Sep-15

Distribution pattern

U.S. Including: VA, NC

drug · product 4 of 34

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.

D-0614-2016

Recall number: D-0614-2016
Initiated: September 18, 2015
Classification: Class II
Status: Terminated
Recalling firm: Sentara Enterprises
Quantity: 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

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiries: a) 26-Sep-15, b) 16-Sep-15 c) 25-Sep-15, d) 25-Sep-15 e) 20-Sep-15, 26-Sep-15, f) 20-Sep-15, 24-Sep-15, g) 20-Sep-15, 26-Sep-15, h) 20-Sep-15, i) 15-Sep-15, j) 26-Sep-15, k) 25-Sep-15, 26-Sep-15, l) 20-Sep-15, 23-Sep-15, m) 20-Sept-15, 24-Sep-15, 26-Sep-15, n) 23-Sep-15, o) 20-Sep-15, p) 26-Sep-15, q) 20-Sep-15

Distribution pattern

U.S. Including: VA, NC

drug · product 5 of 34

CEFAZOLIN, Packaged as a) 625MG in 6.2ML Syringes, b) 2GM in 20ML Syringes, c) 1GM in 50ML Homepumps, d) 2GM in 100ML Homepumps, and e) 12GM in 600ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.

D-0615-2016

Recall number: D-0615-2016
Initiated: September 18, 2015
Classification: Class II
Status: Terminated
Recalling firm: Sentara Enterprises
Quantity: a) 4 Syringes, b) 49 Syringes, c) 18 Bags, d) 80 Bags, e) 23 Bags

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiries: a) 1-Oct-15, b) 28-Sep-15, 29-Sep-15, c) 30-Sep-15 d) 28-Sep-15, 1-Oct-15 e) 25-Sep-15, 28-Sep-15, 29-Sep-15, 30-Sep-15,1-Oct-15

Distribution pattern

U.S. Including: VA, NC

drug · product 6 of 34

Milrinone in 0.45% NS, Packaged as a) 52MG in 65ML Homepumps, b) 80MG in 100ML Homepumps, c) 92MG in 115ML Homepumps, d) 104MG in 130ML Homepumps, e) 112MG in 140ML Homepumps, f) 120MG in 150ML Homepumps, g) 124MG in 155ML Homepumps, h) 128MG in 160ML, i) 136MG in 170ML Homepumps, j) 144MG in 180ML Homepumps, k) 152MG in 190ML Homepumps, l) 160MG in 200ML Homepumps, m) 172MG in 215ML Homepumps, n) 176MG in 220ML Homepumps, and o) 200MG in 250ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.

D-0616-2016

Recall number: D-0616-2016
Initiated: September 18, 2015
Classification: Class II
Status: Terminated
Recalling firm: Sentara Enterprises
Quantity: a) 7, b) 4, c) 8, d) 8, e) 3, f) 4, g) 4, h) 3, i) 4, j) 4, k) 3, l) 3, m) 9, n) 6, o) 3 Bags

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiries: a) 1-Oct-15, b) 29-Sep-15, c) 25-Sep-15, 30-Sep-15, d) 25-Sep-15, e) 1-Oct-15, f) 29-Sep-15, g) 26-Sep-15, h) 1-Oct-15, i) 29-Sep-15, j) 25-Sep-15, k) 1-Oct-15, l) 25-Sep-15, m) 27-Sep-15, 1-Oct-15, n) 24-Sep-15, 30-Sep-15, o) 25-Sep-15

Distribution pattern

U.S. Including: VA, NC

drug · product 7 of 34

SOLUMEDROL (methylprednisolone succinate) 1GM in NS, Packaged in 100ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.

D-0617-2016

Recall number: D-0617-2016
Initiated: September 18, 2015
Classification: Class II
Status: Terminated
Recalling firm: Sentara Enterprises
Quantity: 7 Bags

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiries: 22-Sep-15, 23-Sep-15

Distribution pattern

U.S. Including: VA, NC

drug · product 8 of 34

INTRALIPID (fat emulsion), Packaged in a) 27ML Homepumps, b) 125ML Homepumps, c) 1800ML Homepumps, d) 2000ML Homepumps e) 2350ML Homepumps, and f) 2800ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.

D-0618-2016

Recall number: D-0618-2016
Initiated: September 18, 2015
Classification: Class II
Status: Terminated
Recalling firm: Sentara Enterprises
Quantity: a) 7 Bags, b) 1 Bag, c) 7 Bags, d) 6 Bags e) 7 Bags, f) 7 Bags

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiries: a) 25-Sep-15, b) 20-Sep-15, c) 24-Sep-15, d) 20-Sep-15, e) 24-Sep-15, f) 26-Sep-15

Distribution pattern

U.S. Including: VA, NC

drug · product 9 of 34

POTASSIUM CHLORIDE in D 5 1/2NS, Packaged in a) 40 mEq KCL/LITER 1000ML Homepumps and b) 160 mEq KCL/LITER 500ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.

D-0619-2016

Recall number: D-0619-2016
Initiated: September 18, 2015
Classification: Class II
Status: Terminated
Recalling firm: Sentara Enterprises
Quantity: a) 7 Bags, b) 2 Bags

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiries: a) 30-Sep-15, b) 30-Sep-15

Distribution pattern

U.S. Including: VA, NC

drug · product 10 of 34

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 23320-5176.

D-0620-2016

Recall number: D-0620-2016
Initiated: September 18, 2015
Classification: Class II
Status: Terminated
Recalling firm: Sentara Enterprises
Quantity: a) 1 Bag b) 7 Bags c) 8 Bags

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiries: a) 25-Sep-15, b) 30-Sep-15, c) 28-Sep-15, 1-Oct-15

Distribution pattern

U.S. Including: VA, NC

drug · product 11 of 34

CEFTRIAXONE in NS, Packaged as a) 1GM in 50ML Homepumps, b) 2GM in 100ML Homepumps, and c) 8GM in 200ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.

D-0621-2016

Recall number: D-0621-2016
Initiated: September 18, 2015
Classification: Class II
Status: Terminated
Recalling firm: Sentara Enterprises
Quantity: a) 8 Bags, b) 70 Bags c) 4 Bags

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiries: a) 26-Sep-15, 27-Sep-15, b) 21-Sep-15, 24-Sep-15, 25-Sep-15, 26-Sep-15, 27-Sep-15, c) 25-Sep-15

Distribution pattern

U.S. Including: VA, NC

drug · product 12 of 34

DOBUTAMINE HCL in D5W, Packaged as a) 240MG in 60ML Homepumps and b) 1520MG in 380ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.

D-0622-2016

Recall number: D-0622-2016
Initiated: September 18, 2015
Classification: Class II
Status: Terminated
Recalling firm: Sentara Enterprises
Quantity: a) 7 Bags, b) 4 Bags

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiries: a) 30-Sep-15, b) 25-Sep-15

Distribution pattern

U.S. Including: VA, NC

drug · product 13 of 34

VANCOMYCIN HCL, Packaged as: a) 600MG in 120ML Homepumps, b) 750MG in 150ML Homepumps, c) 850MG in 170ML Homepumps, d) 1GM in 200ML Homepumps, e) 1.25GM in 250ML Homepumps, f) 1.5GM in 300ML Homepumps, g) 1.75GM in 350ML Homepumps, h) 2GM in 400ML Homepumps, i) 4000MG in 800ML Homepumps, j) 5000MG in 1000ML Homepumps, k) 6GM in 1200ML Homepumps, l) 7.5GM in 1500ML Homepumps, and m) 9000MG in 1800ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.

D-0623-2016

Recall number: D-0623-2016
Initiated: September 18, 2015
Classification: Class II
Status: Terminated
Recalling firm: Sentara Enterprises
Quantity: a) 12 Bags, b) 36 Bags, c) 8 Bags, d) 65 Bags, e) 18 Bags, f) 36 Bags g) 21 Bags, h) 7 Bags, i) 3 Bags, j) 3 Bags, k) 2 Bags, l) 6 Bags, m) 3 Bags

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiries: a) 29-Sep-15, 30-Sep-15, b) 25-Sep-15, 29-Sep-15, c) 25-Sep-15 d) 25-Sep-15, 26-Sep-15, 29-Sep-15, e) 25-Sep-15, 1-Oct-15, f) 28-Sep-15, 29-Sep-15, 1-Oct-15, g) 25-Sep-15, h) 25-Sep-15, 27-Sep-15, 29-Sep-15, i) 29-Sep-15, j) 25-Sep-15, 26-Sep-15, k) 29-Sep-15, l) 25-Sep-15, 27-Sep-15, 30-Sep-15, m) 1-Oct-15

Distribution pattern

U.S. Including: VA, NC

drug · product 14 of 34

ONDANSETRON HCL 8MG, Packaged in 100ML Homepumps. Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.

D-0624-2016

Recall number: D-0624-2016
Initiated: September 18, 2015
Classification: Class II
Status: Terminated
Recalling firm: Sentara Enterprises
Quantity: 77 Bags

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiries: 25-Sep-15, 28-Sep-15, 29-Sep-15, 1-Oct-15

Distribution pattern

U.S. Including: VA, NC

drug · product 15 of 34

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 HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.

D-0625-2016

Recall number: D-0625-2016
Initiated: September 18, 2015
Classification: Class II
Status: Terminated
Recalling firm: Sentara Enterprises
Quantity: a) 42 Syringes, b) 6 Bags, c) 4 Bags, d) 4 Bags, e) 1 Bag

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiries: a) 29-Sep-15 b) 30-Sep-15 c) 1-Oct-15, d) 30-Sep-15, e) 30-Sep-15

Distribution pattern

U.S. Including: VA, NC

drug · product 16 of 34

GANCICLOVIR in NS, Packaged as a) 320MG in 64ML Homepumps and b) 2440MG in 488ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.

D-0626-2016

Recall number: D-0626-2016
Initiated: September 18, 2015
Classification: Class II
Status: Terminated
Recalling firm: Sentara Enterprises
Quantity: a) 22 Bags, b) 3 Bags

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiries: a) 25-Sep-15, 1-Oct-15, b) 28-Sep-15

Distribution pattern

U.S. Including: VA, NC

drug · product 17 of 34

ASCORBIC ACID 500MG/Syringe, Packaged in 1ML Syringes, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.

D-0627-2016

Recall number: D-0627-2016
Initiated: September 18, 2015
Classification: Class II
Status: Terminated
Recalling firm: Sentara Enterprises
Quantity: 7 Syringes

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiry: 27-Sep-15

Distribution pattern

U.S. Including: VA, NC

drug · product 18 of 34

Invanz (ertapenem) Injection Recon Soln in NS, Packaged as a) 500MG in 50ML Homepumps and b) 1 GM in 100ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.

D-0628-2016

Recall number: D-0628-2016
Initiated: September 18, 2015
Classification: Class II
Status: Terminated
Recalling firm: Sentara Enterprises
Quantity: a) 3 Bags, b) 60 Bags

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiries: a) 22-Sep-15, b) 19-Sep-15, 20-Sep-15, 22-Sep-15, 23-Sep-15, 24-Sep-15, 25-Sep-15

Distribution pattern

U.S. Including: VA, NC

drug · product 19 of 34

CEFEPIME, Packaged a) 1GM in 50ML Homepumps, b) 2GM in 100ML Homepumps, and c) 12GM in 600ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.

D-0629-2016

Recall number: D-0629-2016
Initiated: September 18, 2015
Classification: Class II
Status: Terminated
Recalling firm: Sentara Enterprises
Quantity: a) 21 Bags, b) 26 Bags c) 3 Bags

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiries: a) 1-Oct-15, b) 30-Sep-15, 1-Oct-15, c) 28-Sep-15

Distribution pattern

U.S. Including: VA, NC

drug · product 20 of 34

ZOSYN (pipericillin/tazobactam) in NS, Packaged as a) 3.375GM in 50ML Homepumps, b) 4.5GM in 100ML Homepumps, c) 18GM in 267ML Homepumps, d) 27GM in 400ML Homepumps, and e) 36GM in 533ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.

D-0630-2016

Recall number: D-0630-2016
Initiated: September 18, 2015
Classification: Class II
Status: Terminated
Recalling firm: Sentara Enterprises
Quantity: a) 56 Bags b) 28 Bags c) 4 Bags, d) 10 Bags e) 2 Bags

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiries: a) 1-Oct-15 b) 28-Sep-15 c) 25-Sep-15, 29-Sep-15, d) 26-Sep-15, 29-Sep-15 e) 1-Oct-15

Distribution pattern

U.S. Including: VA, NC

drug · product 21 of 34

MORPHINE 10MG/ML in NS, Packaged in a) 150ML Homepumps and b) 250ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.

D-0631-2016

Recall number: D-0631-2016
Initiated: September 18, 2015
Classification: Class II
Status: Terminated
Recalling firm: Sentara Enterprises
Quantity: a) 5 Bags, b) 4 Bags

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiries: a) 25-Sep-15, b) 30-Sep-15

Distribution pattern

U.S. Including: VA, NC

drug · product 22 of 34

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.

D-0632-2016

Recall number: D-0632-2016
Initiated: September 18, 2015
Classification: Class II
Status: Terminated
Recalling firm: Sentara Enterprises
Quantity: a)1 Bag, b) 4 Bags

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiries: a) 27-Sep-15, b) 28-Sep-15, 30-Sep-15

Distribution pattern

U.S. Including: VA, NC

drug · product 23 of 34

FLUCONAZOLE IN NACL 400MG in NS, Packaged in 200ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.

D-0633-2016

Recall number: D-0633-2016
Initiated: September 18, 2015
Classification: Class II
Status: Terminated
Recalling firm: Sentara Enterprises
Quantity: 7 Bags

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiry: 25-Sep-15

Distribution pattern

U.S. Including: VA, NC

drug · product 24 of 34

Ampicillin/Sulbactam 12GM in NS, Packaged in 600ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.

D-0634-2016

Recall number: D-0634-2016
Initiated: September 18, 2015
Classification: Class II
Status: Terminated
Recalling firm: Sentara Enterprises
Quantity: 9 Bags

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiries: 17-Sep-15, 19-Sep-15

Distribution pattern

U.S. Including: VA, NC

drug · product 25 of 34

Nafcillin 2GM in NS, Packaged in 50ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.

D-0635-2016

Recall number: D-0635-2016
Initiated: September 18, 2015
Classification: Class II
Status: Terminated
Recalling firm: Sentara Enterprises
Quantity: 28 Bags

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiry: 27-Sep-15

Distribution pattern

U.S. Including: VA, NC

drug · product 26 of 34

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.

D-0636-2016

Recall number: D-0636-2016
Initiated: September 18, 2015
Classification: Class II
Status: Terminated
Recalling firm: Sentara Enterprises
Quantity: a) 4 Bags b) 3 Bags c) 6 Bags

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiries: a) 28-Sep-15 b) 14-Sept-15 c) 1-Oct-15

Distribution pattern

U.S. Including: VA, NC

drug · product 27 of 34

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.

D-0637-2016

Recall number: D-0637-2016
Initiated: September 18, 2015
Classification: Class II
Status: Terminated
Recalling firm: Sentara Enterprises
Quantity: 7 Bags

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiry: 30-Sep-15

Distribution pattern

U.S. Including: VA, NC

drug · product 28 of 34

AZACTAM (aztreonam) 2GM in NS, Packaged in 100ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.

D-0638-2016

Recall number: D-0638-2016
Initiated: September 18, 2015
Classification: Class II
Status: Terminated
Recalling firm: Sentara Enterprises
Quantity: 12 Bags

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiry: 30-Sep-15

Distribution pattern

U.S. Including: VA, NC

drug · product 29 of 34

CLINDAMYCIN 120MG in NS, Package in 20ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.

D-0639-2016

Recall number: D-0639-2016
Initiated: September 18, 2015
Classification: Class II
Status: Terminated
Recalling firm: Sentara Enterprises
Quantity: 6 Bags

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiry: 29-Sep-15

Distribution pattern

U.S. Including: VA, NC

drug · product 30 of 34

Solu-Cortef (hydrocortisone) 1MG in NS, Packaged in 0.1ML Syringe, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.

D-0640-2016

Recall number: D-0640-2016
Initiated: September 18, 2015
Classification: Class II
Status: Terminated
Recalling firm: Sentara Enterprises
Quantity: 9 Bags

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiries: 28-Sep-15, 30-Sep-15

Distribution pattern

U.S. Including: VA, NC

drug · product 31 of 34

GENTAMICIN, Packaged as a) 70MG in 70ML Homepumps, b) 80MG in 80ML Homepumps, and c) 375MG in a 75ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.

D-0641-2016

Recall number: D-0641-2016
Initiated: September 18, 2015
Classification: Class II
Status: Terminated
Recalling firm: Sentara Enterprises
Quantity: a) 11 bags, b) 9 Bags, c) 3 Bags

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiries: a) 30-Sep-15, b) 25-Sep-15, c) 24-Sep-15

Distribution pattern

U.S. Including: VA, NC

drug · product 32 of 34

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

D-0642-2016

Recall number: D-0642-2016
Initiated: September 18, 2015
Classification: Class II
Status: Terminated
Recalling firm: Sentara Enterprises
Quantity: 1 Bag

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiry: 29-Sep-15

Distribution pattern

U.S. Including: VA, NC

drug · product 33 of 34

Dextrose-5% Lactated Ringers, Packaged in 3000ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.

D-0643-2016

Recall number: D-0643-2016
Initiated: September 18, 2015
Classification: Class II
Status: Terminated
Recalling firm: Sentara Enterprises
Quantity: 7 Bags

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiry: 28-Sep-15

Distribution pattern

U.S. Including: VA, NC

drug · product 34 of 34

MYCAMINE (micafungin sodium) 150MG, Packaged in 150ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.

D-0644-2016

Recall number: D-0644-2016
Initiated: September 18, 2015
Classification: Class II
Status: Terminated
Recalling firm: Sentara Enterprises
Quantity: 10 Bags

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiries: 24-Sep-15, 27-Sep-15

Distribution pattern

U.S. Including: VA, NC

Event summary

Source snapshots represented here

Every recalled product in this event

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