U.S. Recalls in October 2016

October 2016 recalls — page 8

These records include useful source details for the selected month.

2016 archive →

DrugOct 19, 2016

Pharmedium Services methadone HCl, 2.5 mg per 0.5 mL, in 0.9% Sodium Chloride, 0.5 mL Total recall — FDA D-0071-2017

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, 1 mg per 5 mL, 5 mL Total Volume in a recall — FDA D-0046-2017

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-0034-2017

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

Class IIFDA: TerminatedPharmedium Services, LLC

DrugOct 19, 2016

Pharmedium Services fentaNYL Citrate, 10 mcg per 1 mL, in 0.9% Sodium Chloride, Preservative recall — FDA D-0093-2017

Subpotent Drug: confirmed subpotency in one lot of this product that was packaged and stored in syringes.

Class IFDA: TerminatedPharmedium Services, LLC

DrugOct 19, 2016

Leiter's Compounding Lidocaine HCl 1% - Phenylephrine HCl 1.5% in Sterile Water for recall — FDA D-0014-2017

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

Class IIFDA: TerminatedLeiter's Compounding

DrugOct 19, 2016

Pharmedium Services lidocaine HCl 1%, 10 mg per mL (50 mg per 5 mL), Preservative Free, 5 mL recall — FDA D-0064-2017

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 ePHEDrine Sulfate, 10 mg per mL, 50 mg per 5 mL, in 0.9% Sodium recall — FDA D-0030-2017

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 Vancomycin 10 mg/mL in 0.9% Sodium Chloride (Injection) 1 mL Total recall — FDA D-0018-2017

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, 5 mg per 5 mL, 5 mL Total Volume recall — FDA D-0082-2017

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

Allergan Sales TAZORAC (tazarotene) Gel 0.05% recall — FDA D-0099-2017

Failed Content Uniformity Specifications

Class IIFDA: TerminatedAllergan Sales, LLC

DrugOct 19, 2016

Pharmedium Services midazolam HCl, 1 mg per mL (3 mg per 3 mL), in 0.9% Sodium Chloride, 3 recall — FDA D-0074-2017

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%, Preservative Free, 20 mg per mL (100 mg per 5 mL), 5 recall — FDA D-0067-2017

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 HEPARIN Sodium Inj recall — FDA D-0049-2017

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

Class IIFDA: TerminatedPharmedium Services, LLC

DrugOct 19, 2016

Pharmedium Services neostigmine Methylsulfate, 1 mg per mL, 3 mg per 3 mL, 3 mL Total Volume recall — FDA D-0084-2017

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, 5 mcg per mL (10 mcg per 2 mL) in 0.9% Sodium recall — FDA D-0043-2017

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 HEPARIN Sodium Inj., USP, 5,000 USP Heparin Units per 5 mL Total Volume recall — FDA D-0048-2017

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, 10 mcg per mL (25 mcg per 2.5 mL), in 0.9% Sodium recall — FDA D-0041-2017

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 HEPARIN Sodium Inj recall — FDA D-0047-2017

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 (60 mg per 3 mL), 3 mL Total Volume in a recall — FDA D-0069-2017

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 ePHEDrine Sulfate, 5 mg per mL, 25 mg per 5 mL, in 0.9% Sodium Chloride recall — FDA D-0029-2017

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, 5 mcg per mL, 0.9% Sodium Chloride, Preservative Free recall — FDA D-0042-2017

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 ketamine HCl Injection, 50 mg per mL (100 mg per 2 mL), 2 mL Total recall — FDA D-0057-2017

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 Cefuroxime Sodium 10 mg/mL in 0.9% Sodium Chloride (Injection) 1 mL recall — FDA D-0012-2017

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

Class IIFDA: TerminatedLeiter's Compounding

DrugOct 19, 2016

Pharmedium Services PHENYLephrine HCl, 100 mcg per mL, 0.5 mg per 5 mL, in 0.9% Sodium recall — FDA D-0086-2017

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 8

How to use this monthly recall archive