Drug and pharmaceutical recalls
17628 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2016-10-19FDA-DrugPharmedium Services, LLCClass IIketamine 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.
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
- 2016-10-19FDA-DrugPharmedium Services, LLCClass IIHYDROmorphone 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
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
- 2016-10-19FDA-DrugPharmedium Services, LLCClass IIHYDROmorphone HCl, 0.5 mg per mL in 0.9% Sodium Chloride, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3352.
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
- 2016-10-19FDA-DrugPharmedium Services, LLCClass IIHYDROmorphone HCl, 0.2 mg per mL, (0.4 mg per 2 mL), in 0.9% Sodium Chloride, 2 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3162.
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
- 2016-10-19FDA-DrugPharmedium Services, LLCClass IIHEPARIN Sodium Inj. USP, 3,000 USP Heparin Units per 3 mL Total Volume in a syringe, NOT FOR LOCK FLUSH, 1,000 Heparin USP Units per mL, Rx only, PharMEDium, Product code 2K1926.
Subpotent Drug and Stability Data Does Not Support Expiry: confirmed subpotency and potential loss of potency in drugs packaged and stored in syringes.
- 2016-10-19FDA-DrugPharmedium Services, LLCClass IIHEPARIN Sodium Inj., USP, 5,000 USP Heparin Units per 5 mL Total Volume in a syringe, NOT FOR LOCK FLUSH, 1,000 USP Heparin Units per mL, Rx only, PharMEDium, Product code 2K1925.
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
- 2016-10-19FDA-DrugPharmedium Services, LLCClass IIHEPARIN 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.
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
- 2016-10-19FDA-DrugPharmedium Services, LLCClass IIglycopyrrolate, 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.
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
- 2016-10-19FDA-DrugPharmedium Services, LLCClass IIglycopyrrolate, 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.
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
- 2016-10-19FDA-DrugPharmedium Services, LLCClass IIglycopyrrolate, 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.
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
- 2016-10-19FDA-DrugPharmedium Services, LLCClass IIfentaNYL 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.
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
- 2016-10-19FDA-DrugPharmedium Services, LLCClass IIfentaNYL 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.
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
- 2016-10-19FDA-DrugPharmedium Services, LLCClass IIfentaNYL 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.
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
- 2016-10-19FDA-DrugPharmedium Services, LLCClass IIfentaNYL 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.
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
- 2016-10-19FDA-DrugPharmedium Services, LLCClass IIfentaNYL 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.
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
- 2016-10-19FDA-DrugPharmedium Services, LLCClass IIfentaNYL 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.
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
- 2016-10-19FDA-DrugPharmedium Services, LLCClass IIfentaNYL Citrate Injection, 50 mcg per mL (100 mcg per 2 mL), 2 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3303.
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
- 2016-10-19FDA-DrugPharmedium Services, LLCClass IIfentaNYL 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.
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
- 2016-10-19FDA-DrugPharmedium Services, LLCClass IIfentaNYL 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.
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
- 2016-10-19FDA-DrugPharmedium Services, LLCClass IIfentaNYL Citrate Injection, 50 mcg per mL, Preservative Free, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3153.
Subpotent Drug and Stability Data Does Not Support Expiry: confirmed subpotency and potential loss of potency in drugs packaged and stored in syringes.
- 2016-10-19FDA-DrugPharmedium Services, LLCClass IIfentaNYL 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
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
- 2016-10-19FDA-DrugPharmedium Services, LLCClass IIFentanyl 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.
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
- 2016-10-19FDA-DrugPharmedium Services, LLCClass IIePHEDrine Sulfate, 10 mg per mL, in 0.9% Sodium Chloride, Preservative Free, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3347.
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
- 2016-10-19FDA-DrugPharmedium Services, LLCClass IIePHEDrine 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.
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
- 2016-10-19FDA-DrugPharmedium Services, LLCClass IIePHEDrine 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.
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
- 2016-10-19FDA-DrugPharmedium Services, LLCClass IIBuffered Lidocaine, 2%, In Sodium Bicarbonate 8.4%, 3 mL Total Volume in a syringe, Local anesthetic use, Rx only, PharMEDium, Product code 2K2475.
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
- 2016-10-19FDA-DrugPharmedium Services, LLCClass IIBuffered Lidocaine, 1%, In Sodium Bicarbonate 8.4%, 1 mL Total Volume in a syringe, Local anesthetic use, Rx only, PharMEDium, Product code 2K2466.
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
- 2016-10-19FDA-DrugPharmedium Services, LLCClass IIatropine 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.
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
- 2016-10-19FDA-DrugPharmedium Services, LLCClass IIatropine Sulfate Injection, 0.4 mg per mL, 1 mg per 2.5 mL, 2.5 mL Total Volume in a syringe, For IV use, Rx only, PharMEDium, Product code 2R3324.
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
- 2016-10-19FDA-DrugTeva Pharmaceuticals USAClass IIAmikacin Sulfate Injection, USP, 1 gm/4 mL (250 mg/mL) Rx Only, Manufactured in Hungary For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0703-9040-01 (individual pack), NDC 0703-9040-03 (shelf-pack carton of 10 vials).
CGMP Deviations
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