Drug Recalls

17,680 Records

Prescription & OTC drug enforcement reports

201 results found for potency Page 7 of 9
Pharmedium Services, LLC
Class II Terminated
ketamine HCl, 10 mg per mL, 20 mg per 2 mL, in 0.9% Sodium Chloride, 2 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3330.
Reason: Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
D-0055-2017 October 19, 2016 Lake Forest, IL
Pharmedium Services, LLC
Class II Terminated
morphine Sulfate, 1 mg per mL (5 mg per 5 mL), in 0.9% Sodium Chloride, Preservative Free (Contains Sulfites), 5 mL Total Volume in a syringe, For IV use, Rx only, PharMEDium, Product code 2R3181.
Reason: Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
D-0078-2017 October 19, 2016 Lake Forest, IL
Pharmedium Services, LLC
Class II Terminated
midazolam HCl, 1 mg per mL (2 mg per 2 mL), in 0.9% Sodium Chloride, 2 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3356.
Reason: Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
D-0075-2017 October 19, 2016 Lake Forest, IL
Pharmedium Services, LLC
Class II Terminated
lidocaine HCl, 1%, 10 mg per 1 mL, 1 mL Total Volume in a syringe, Rx only, PharMEDium, Product code 2R3102.
Reason: Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
D-0060-2017 October 19, 2016 Lake Forest, IL
Pharmedium Services, LLC
Class II Terminated
lidocaine HCl, 0.5%, 5 mg per mL, in 0.9% Sodium Chloride, 1 mL Total Volume in a syringe, Rx only, PharMEDium, Product code 2R3140.
Reason: Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
D-0059-2017 October 19, 2016 Lake Forest, IL
Pharmedium Services, LLC
Class II Terminated
fentaNYL Citrate, 25 mcg per mL in 0.9% Sodium chloride, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3236.
Reason: Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
D-0036-2017 October 19, 2016 Lake Forest, IL
Pharmedium Services, LLC
Class II Terminated
neostigmine Methylsulfate, 1 mg per mL, 5 mg per 5 mL, 5 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3326.
Reason: Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
D-0082-2017 October 19, 2016 Lake Forest, IL
Pharmedium Services, LLC
Class II Terminated
ketamine HCl, 10 mg per mL, 50 mg per 5 mL, in 0.9% Sodium Chloride, 5 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3234.
Reason: Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
D-0053-2017 October 19, 2016 Lake Forest, IL
Pharmedium Services, LLC
Class II Terminated
fentaNYL Citrate Injection, 50 mcg per mL, 250 mcg per 5 mL, 5mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3306.
Reason: Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
D-0038-2017 October 19, 2016 Lake Forest, IL
Pharmedium Services, LLC
Class II Terminated
HYDROmorphone HCl, 1 mg per mL, in 0.9% Sodium Chloride, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2T6165
Reason: Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
D-0052-2017 October 19, 2016 Lake Forest, IL
Pharmedium Services, LLC
Class II Terminated
lidocaine HCl, 2%, 40 mg per 2 mL, 2 mL Total Volume in a syringe, Rx only, PharMEDium, Product code 2R3112.
Reason: Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
D-0065-2017 October 19, 2016 Lake Forest, IL
Pharmedium Services, LLC
Class II Terminated
Buffered Lidocaine, 1%, In Sodium Bicarbonate 8.4%, 1 mL Total Volume in a syringe, Local anesthetic use, Rx only, PharMEDium, Product code 2K2466.
Reason: Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
D-0027-2017 October 19, 2016 Lake Forest, IL
Pharmedium Services, LLC
Class II Terminated
neostigmine Methylsulfate, 1 mg per mL, 2 mg per 2 mL, 2 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3550.
Reason: Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
D-0083-2017 October 19, 2016 Lake Forest, IL
Pharmedium Services, LLC
Class II Terminated
lidocaine HCl, 2%, 20 mg per mL (60 mg per 3 mL), 3 mL Total Volume in a syringe, Rx only, PharMEDium, Product code 2R3450.
Reason: Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
D-0069-2017 October 19, 2016 Lake Forest, IL
Hospira Inc., A Pfizer Company
Class II Terminated
Marcaine 0.5% (bupivacaine HCl) injection, USP, 250 mg/50 mL (5 mg/mL), 50 mL Multiple-Dose Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1610-50.
Reason: 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...
D-0097-2017 October 19, 2016 Lake Forest, IL
Pharmedium Services, LLC
Class II Terminated
labetalol HCl, 5 mg per mL, 20 mg per 4 mL, 4 mL total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3117.
Reason: Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
D-0058-2017 October 19, 2016 Lake Forest, IL
Pharmedium Services, LLC
Class I Terminated
fentaNYL Citrate, 10 mcg per 1 mL, in 0.9% Sodium Chloride, Preservative Free, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3174.
Reason: Subpotent Drug: confirmed subpotency in one lot of this product that was packaged and stored in syringes.
D-0093-2017 October 19, 2016 Lake Forest, IL
Pharmedium Services, LLC
Class II Terminated
rocuronium Bromide, 10 mg per mL, 50 mg per 5 mL, Preservative Free, 5 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3321.
Reason: Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
D-0089-2017 October 19, 2016 Lake Forest, IL
Pharmedium Services, LLC
Class II Terminated
remifentanil HCl, 50 mcg per mL, 100 mcg per 2 mL, in 0.9% Sodium Chloride, Preservative Free, 2 mL Total Volume in a syringe, Rx only, PharMEDium, Product code 2R3300.
Reason: Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
D-0088-2017 October 19, 2016 Lake Forest, IL
Hospira Inc., A Pfizer Company
Class II Terminated
Marcaine 0.25% (bupivacaine HCl) injection, USP, 125 mg/50 mL (2.5 mg/mL), 50 mL Multiple-Dose Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1587-50.
Reason: 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...
D-0096-2017 October 19, 2016 Lake Forest, IL
Pharmedium Services, LLC
Class II Terminated
fentaNYL Citrate, 5 mcg per mL, 15 mcg per 3mL, in 0.9% Sodium chloride, 3 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3318.
Reason: Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
D-0039-2017 October 19, 2016 Lake Forest, IL
Pharmedium Services, LLC
Class II Terminated
methadone HCl, 1 mg per mL, in 0.9% Sodium Chloride, 1 mL Total Volume in a syringe, For IV Use Only, Rx only, PharMEDium, Product code 2T6120.
Reason: Stability Data Does Not Support Expiry:potential loss of potency in drugs packaged and stored in syringes.
D-0070-2017 October 19, 2016 Lake Forest, IL
Pharmedium Services, LLC
Class II Terminated
glycopyrrolate, 0.2 mg per mL, 0.4 mg per 2 mL, 2 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3329.
Reason: Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
D-0045-2017 October 19, 2016 Lake Forest, IL
Pharmedium Services, LLC
Class II Terminated
fentaNYL Citrate, 5 mcg per mL (10 mcg per 2 mL) in 0.9% Sodium chloride, 2 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3339.
Reason: Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
D-0040-2017 October 19, 2016 Lake Forest, IL
Pharmedium Services, LLC
Class II Terminated
ketamine HCl Injection, 50 mg per mL, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3348.
Reason: Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
D-0056-2017 October 19, 2016 Lake Forest, IL