U.S. Recalls in October 2016

October 2016 recalls — page 9

These records include useful source details for the selected month.

2016 archive →

DrugOct 19, 2016

Pharmedium Services atropine Sulfate Injection, 0.4 mg per mL, 0.8 mg per 2 mL, 2 mL Total recall — FDA D-0026-2017

Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.

Class IIFDA: TerminatedPharmedium Services, LLC

DrugOct 19, 2016

Pharmedium Services PHENYLephrine HCl, 100 mcg per mL, 0.5 mg per 5 mL, in 0.9% Sodium recall — FDA D-0087-2017

Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.

Class IIFDA: TerminatedPharmedium Services, LLC

DrugOct 19, 2016

Pharmedium Services fentaNYL Citrate Injection, 50 mcg per mL, Preservative Free, 1 mL Total recall — FDA D-0033-2017

Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.

Class IIFDA: TerminatedPharmedium Services, LLC

DrugOct 19, 2016

Pharmedium Services fentaNYL Citrate Injection, 50 mcg per mL, 250 mcg per 5 mL, 5mL Total recall — FDA D-0038-2017

Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.

Class IIFDA: TerminatedPharmedium Services, LLC

DrugOct 19, 2016

Leiter's Compounding Moxifloxacin 1 mg/mL in Sterile Balanced Salt Solution (BSS) recall — FDA D-0016-2017

Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters

Class IIFDA: TerminatedLeiter's Compounding

DrugOct 19, 2016

Marcaine 0.25% (bupivacaine HCl) injection, USP, 125 mg/50 mL (2.5 mg/mL), 50 mL recall — FDA D-0096-2017

Lack of Assurance of Sterility and Subpotent Drug: defect in glass vial prevented stopper from forming a seal allowing water to ingress and dilute the product causing it to be less than the…

Class IIFDA: TerminatedHospira Inc., A Pfizer Company

DrugOct 19, 2016

Pharmedium Services HYDROmorphone HCl, 0.5 mg per mL in 0.9% Sodium Chloride, 1 mL Total recall — FDA D-0051-2017

Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.

Class IIFDA: TerminatedPharmedium Services, LLC

DrugOct 19, 2016

Pharmedium Services remifentanil HCl, 50 mcg per mL, 100 mcg per 2 mL, in 0.9% Sodium recall — FDA D-0088-2017

Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.

Class IIFDA: TerminatedPharmedium Services, LLC

DrugOct 19, 2016

Pharmedium Services lidocaine HCl, 0.5%, 5 mg per mL, in 0.9% Sodium Chloride, 1 mL Total recall — FDA D-0059-2017

Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.

Class IIFDA: TerminatedPharmedium Services, LLC

DrugOct 19, 2016

Pharmedium Services labetalol HCl, 5 mg per mL, 20 mg per 4 mL, 4 mL total Volume in a recall — FDA D-0058-2017

Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.

Class IIFDA: TerminatedPharmedium Services, LLC

DrugOct 19, 2016

Pharmedium Services fentaNYL Citrate, 25 mcg per mL in 0.9% Sodium chloride, 1 mL Total recall — FDA D-0036-2017

Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.

Class IIFDA: TerminatedPharmedium Services, LLC

DrugOct 19, 2016

Leiter's Compounding Brilliant Blue G 0.025% in 0.9% Sodium Chloride (Injection) 1 mL Total recall — FDA D-0011-2017

Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters

Class IIFDA: TerminatedLeiter's Compounding

DrugOct 19, 2016

Pharmedium Services neostigmine Methylsulfate, 1 mg per mL, 2 mg per 2 mL, 2 mL Total Volume recall — FDA D-0083-2017

Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.

Class IIFDA: TerminatedPharmedium Services, LLC

DrugOct 19, 2016

Pharmedium Services Fentanyl Citrate 16.67 mcg per mL and Bupivacaine HCl 0.1667% in 0.9% recall — FDA D-0032-2017

Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.

Class IIFDA: TerminatedPharmedium Services, LLC

DrugOct 19, 2016

Pharmedium Services lidocaine HCl, 2%, 20 mg per mL (100 mg per 5 mL), 5 mL Total Volume in recall — FDA D-0092-2017

Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.

Class IIFDA: TerminatedPharmedium Services, LLC

DrugOct 19, 2016

Leiter's Compounding Atropine Sulfate 0.01% in 0.9% Sodium Chloride (Ophthalmic Solution) 10 recall — FDA D-0010-2017

Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters

Class IIFDA: TerminatedLeiter's Compounding

DrugOct 19, 2016

Amerisource Health Services Paricalcitol Capsules, 1 mcg recall — FDA D-0009-2017

Failed Impurities/Degradation Specifications: This repackaged product was recalled by its manufacturer due to failed results for impurities.

Class IIIFDA: TerminatedAmerisource Health Services

DrugOct 19, 2016

Pharmedium Services morphine Sulfate, 0.5 mg per mL, in 0.9% Sodium Chloride, Preservative recall — FDA D-0076-2017

Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.

Class IIFDA: TerminatedPharmedium Services, LLC

DrugOct 19, 2016

Pharmedium Services morphine Sulfate, 1 mg per mL (2 mg per 2 mL), in 0.9% Sodium Chloride recall — FDA D-0079-2017

Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.

Class IIFDA: TerminatedPharmedium Services, LLC

DrugOct 19, 2016

Bee Xtreme Oasis Dietary Supplement Capsules, 500 mg, 45 count bottles recall — FDA D-0020-2017

Marketed without an Approved NDA/ANDA; FDA analysis found them to contain sibutramine and phenolphthalein

Class IFDA: TerminatedBee Xtreme

DrugOct 19, 2016

Pharmedium Services midazolam HCl, 1 mg per mL (2 mg per 2 mL), in 0.9% Sodium Chloride, 2 recall — FDA D-0075-2017

Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.

Class IIFDA: TerminatedPharmedium Services, LLC

DrugOct 19, 2016

Pharmedium Services morphine Sulfate, 0.5 mg per mL, in 0.9% Sodium Chloride, Preservative recall — FDA D-0077-2017

Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.

Class IIFDA: TerminatedPharmedium Services, LLC

DrugOct 19, 2016

Pharmedium Services glycopyrrolate, 0.2 mg per mL, 0.6 mg per 3 mL, 3 mL Total Volume in a recall — FDA D-0044-2017

Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.

Class IIFDA: TerminatedPharmedium Services, LLC

DrugOct 19, 2016

Pharmedium Services lidocaine HCl, 1%, 10 mg per mL (50 mg per 5 mL), 5 mL Total Volume in a recall — FDA D-0062-2017

Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.

Class IIFDA: TerminatedPharmedium Services, LLC

How to use this monthly recall archive

Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.

U.S. Recalls — October 2016

October 2016 recalls — page 9

How to use this monthly recall archive