FDA Recall
Terminated
Historical recordClass II
HEPARIN Sodium Inj. USP, 15,000 USP Heparin Units per 3 mL Injection 3 mL Total Volume in a syringe, Rx only, PharMEDium, Product code 2K1210.
by PharMEDium Services, LLC
- Reason
- Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
- Published
- October 19, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
glycopyrrolate, 0.2 mg per mL, 1 mg per 5 mL, 5 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3340.
by PharMEDium Services, LLC
- Reason
- Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
- Published
- October 19, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
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.
by PharMEDium Services, LLC
- Reason
- Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
- Published
- October 19, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
glycopyrrolate, 0.2 mg per mL, 0.6 mg per 3 mL, 3 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3217.
by PharMEDium Services, LLC
- Reason
- Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
- Published
- October 19, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
fentaNYL Citrate, 5 mcg per mL (10 mcg per 2 mL) in 0.9% Sodium chloride, 2 mL Total Volume in a 3 mL BD Syringe, For IV Use Only, Rx only, PharMEDium, Product code 2T6107.
by PharMEDium Services, LLC
- Reason
- Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
- Published
- October 19, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
fentaNYL Citrate, 5 mcg per mL, 0.9% Sodium Chloride, Preservative Free, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3479.
by PharMEDium Services, LLC
- Reason
- Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
- Published
- October 19, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
fentaNYL Citrate, 10 mcg per mL (25 mcg per 2.5 mL), in 0.9% Sodium Chloride, 2.5 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3424.
by PharMEDium Services, LLC
- Reason
- Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
- Published
- October 19, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
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.
by PharMEDium Services, LLC
- Reason
- Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
- Published
- October 19, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
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.
by PharMEDium Services, LLC
- Reason
- Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
- Published
- October 19, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
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.
by PharMEDium Services, LLC
- Reason
- Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
- Published
- October 19, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
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.
by PharMEDium Services, LLC
- Reason
- Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
- Published
- October 19, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
fentaNYL Citrate Injection, 50 mcg per mL, Preservative Free, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3153.
by PharMEDium Services, LLC
- Reason
- Subpotent Drug and Stability Data Does Not Support Expiry: confirmed subpotency and potential loss of potency in drugs packaged and stored in syringes.
- Published
- October 19, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
fentaNYL Citrate Injection, 50 mcg per mL, Preservative Free, 1 mL Total Volume in a syringe, For IV Use, Product code 2R3118, NDC 61553-118-40
by PharMEDium Services, LLC
- Reason
- Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
- Published
- October 19, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Fentanyl Citrate 16.67 mcg per mL and Bupivacaine HCl 0.1667% in 0.9% Sodium Chloride, Total Dose 25.005 mcg/1.5 mL Fentanyl Citrate, Content Volume 1.5 mL in 3 mL BD Syringe, Intended for Epidural Use, Rx only, PharMEDium, Product code 2T6228.
by PharMEDium Services, LLC
- Reason
- Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
- Published
- October 19, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
ePHEDrine Sulfate, 10 mg per mL, 50 mg per 5 mL, in 0.9% Sodium Chloride, Preservative Free, 5 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3308.
by PharMEDium Services, LLC
- Reason
- Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
- Published
- October 19, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
ePHEDrine Sulfate, 5 mg per mL, 25 mg per 5 mL, in 0.9% Sodium Chloride, Preservative Free, 5 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3301.
by PharMEDium Services, LLC
- Reason
- Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
- Published
- October 19, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Buffered Lidocaine, 2%, In Sodium Bicarbonate 8.4%, 3 mL Total Volume in a syringe, Local anesthetic use, Rx only, PharMEDium, Product code 2K2475.
by PharMEDium Services, LLC
- Reason
- Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
- Published
- October 19, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Buffered Lidocaine, 1%, In Sodium Bicarbonate 8.4%, 1 mL Total Volume in a syringe, Local anesthetic use, Rx only, PharMEDium, Product code 2K2466.
by PharMEDium Services, LLC
- Reason
- Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
- Published
- October 19, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
atropine Sulfate Injection, 0.4 mg per mL, 0.8 mg per 2 mL, 2 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3335.
by PharMEDium Services, LLC
- Reason
- Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
- Published
- October 19, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Amikacin Sulfate Injection, USP, 500 mg/2 mL (250 mg/mL) Rx Only, Manufactured in Hungary For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0703-9032-01 (individual pack), NDC 0703-9032-03 (shelf-pack carton of 10 vials).
by Teva Pharmaceuticals USA
- Reason
- CGMP Deviations
- Published
- October 19, 2016
- Distribution
- Nationwide
View recall →
Recall records are summarized from official FDA and USDA sources. Notices may be updated, reclassified, terminated, or withdrawn. Always review the linked official notice for the most current instructions.
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