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
Monthly breakdown
2016 recalls by month
Select a month to review the recall records reported during that period.
December 2016251 records · 2 categoriesNovember 2016140 records · 2 categoriesOctober 2016469 records · 2 categoriesSeptember 2016304 records · 3 categoriesAugust 2016156 records · 3 categoriesJuly 2016295 records · 2 categoriesJune 2016155 records · 2 categoriesMay 2016210 records · 2 categoriesApril 2016193 records · 2 categoriesMarch 2016166 records · 2 categoriesFebruary 2016176 records · 2 categoriesJanuary 201693 records · 2 categories
2016 recalls — page 25
Records are ordered by the best available source date.
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
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
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.