2016 U.S. Recalls — FDA & NHTSA Archive

Monthly breakdown

2016 recalls by month

Select a month to review the recall records reported during that period.

2016 recalls — page 24

Records are ordered by the best available source date.

DrugOct 19, 2016

Pharmedium Services PHENYLephrine HCl, 40 mcg per mL, 200 mcg per 5 mL, in 0.9% Sodium recall — FDA D-0085-2017

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 Mitomycin 0.02% (0.2 mg/mL) in Sterile Water for Injection (Injection) recall — FDA D-0015-2017

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

Class IIFDA: TerminatedLeiter's Compounding

DrugOct 19, 2016

Bee Xtreme Jenesis Dietary Supplement Capsules, 350 mg, 60 count bottles recall — FDA D-0021-2017

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

Class IFDA: TerminatedBee Xtreme

DrugOct 19, 2016

Pharmedium Services glycopyrrolate, 0.2 mg per mL, 0.4 mg per 2 mL, 2 mL Total Volume in a recall — FDA D-0045-2017

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, 10 mg per mL, 50 mg per 5 mL, 0.9% Sodium Chloride, 5 mL recall — FDA D-0054-2017

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 HYDROmorphone HCl, 0.2 mg per mL, (0.4 mg per 2 mL), in 0.9% Sodium recall — FDA D-0050-2017

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

Marcaine 0.5% (bupivacaine HCl) injection, USP, 250 mg/50 mL (5 mg/mL), 50 mL Multiple-Dose recall — FDA D-0097-2017

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 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

About the 2016 recall archive

This archive groups records by their reported or recall date. It does not imply that every recall was initiated, announced and resolved during the same calendar year. Open the individual record for the exact dates and source details supplied by FDA or NHTSA.

U.S. Recalls in 2016

2016 recalls by month

2016 recalls — page 24

About the 2016 recall archive