Drug Recalls

17,680 Records

Prescription & OTC drug enforcement reports

201 results found for potency Page 5 of 9
Pfizer Inc.
Class I Terminated
Hydromorphone, Hydrochloride, Injection, USP CII, 10 mg/mL, Rx Only, 1 mL Single-dose Vial, High Potency Formulation. Mfd For: Teva Parenteral Medicines, Inc., Irvine, CA 92618. NDC: 0703-0110-01
Reason: Non-Sterility: Confirmed customer complaints of glass product container vials that may be empty or cracked.
D-0596-2018 March 21, 2018 New York, NY
Pfizer Inc.
Class I Terminated
Hydromorphone, Hydrochloride, Injection, USP CII, 10 mg/mL, Rx Only, 1 mL Single-dose Vial, High Potency Formulation. Hospira, Inc., Lake forest, IL 60045 USA. NDC: 0409-2634-01
Reason: Non-Sterility: Confirmed customer complaints of glass product container vials that may be empty or cracked.
D-0597-2018 March 21, 2018 New York, NY
PharMEDium Services, LLC.
Class II Terminated
Hydromorphone HCl 0.5 mg per mL in 0.9% Sodium Chloride Injection 1 mL, packaged in syringes, Rx Only , PharMEDium Services, LLC. 913 N. Davis Ave Cleveland, MS 38732, NDC 61553-352-40
Reason: Superpotent drug: out of specification result for potency
D-0080-2018 November 22, 2017 Memphis, TN
Pfizer Inc.
Class III Terminated
PROTONIX I.V. (pantoprazole sodium) for Injection, Equivalent to 40 mg pantoprazole per vial, For I.V. infusion only, Rx Only, Distributed by Wyeth Pharmaceuticals Inc, A subsidiary of Pfizer Inc, Phi...
Reason: Subpotent Drug: Out of Specification (OOS) for potency at the 6-month stability time point.
D-0516-2017 March 22, 2017 New York, NY
MOORE'S COMPOUNDING PHARMACY
Class II Terminated
Levothyroxine Sodium 135 mcg/Liothyronine 15 mcg SR capsules, 90 count bottles, Rx only, Moore's Pharmacy Compounding, Corpus Christi, TX
Reason: Superpotent Drug and Subpotent Drug; potency failures obtained
D-0488-2017 March 1, 2017 Corpus Christi, TX
Teva Pharmaceuticals USA
Class II Terminated
Amoxicillin for Oral Suspension USP, 125 mg per 5 mL, packaged in a 100 mL bottle, Rx only, Manufactured for: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960, NDC 0093-4150-73
Reason: Subpotency: due to a low, out of specification test result for assay during stability testing.
D-0440-2017 February 1, 2017 North Wales, PA
Town and Country Compounding and Consultation Services, LLC
Class III Terminated
HCG (Chorionic Gonadotropin Lyopholized) II, 1000 unit vial, Rx only, Prepared by Town & Country, Compounding & Consultation Services, 106 Prospect St - 1st FL, Ridgewood, NJ 07459
Reason: Subpotent Drug: due to failed potency results of 74% (spec. 80-125%).
D-0436-2017 January 25, 2017 Ridgewood, NJ
Pharmedium Services, LLC
Class II Terminated
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.
Reason: Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
D-0026-2017 October 19, 2016 Lake Forest, IL
Pharmedium Services, LLC
Class II Terminated
fentaNYL 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.
Reason: Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
D-0037-2017 October 19, 2016 Lake Forest, IL
Pharmedium Services, LLC
Class II Terminated
succinylcholine Chloride Injection, 20 mg per mL, 100 mg per 5 mL, 5 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3357.
Reason: Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
D-0090-2017 October 19, 2016 Lake Forest, IL
Pharmedium Services, LLC
Class II Terminated
morphine Sulfate, 0.5 mg per mL, in 0.9% Sodium Chloride, Preservative Free (Contains Sulfites), 1 mL Total Volume in a syringe, For IV use, Rx only, PharMEDium, Product code 2R3017.
Reason: Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
D-0076-2017 October 19, 2016 Lake Forest, IL
Pharmedium Services, LLC
Class II Terminated
lidocaine HCl, 1%, in 0.9% Sodium Chloride, Preservative Free, Total Volume 1 mL in a syringe, Rx only, PharMEDium, Product code 2R3345.
Reason: Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
D-0063-2017 October 19, 2016 Lake Forest, IL
Pharmedium Services, LLC
Class II Terminated
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.
Reason: Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
D-0030-2017 October 19, 2016 Lake Forest, IL
Pharmedium Services, LLC
Class II Terminated
ePHEDrine 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.
Reason: Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
D-0031-2017 October 19, 2016 Lake Forest, IL
Pharmedium Services, LLC
Class II Terminated
lidocaine HCl, 2%, 20 mg per mL (100 mg per 5 mL), 5 mL Total Volume in a syringe, Rx only, PharMEDium, Product code 2R3110.
Reason: Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
D-0092-2017 October 19, 2016 Lake Forest, IL
Pharmedium Services, LLC
Class II Terminated
lidocaine HCl, 1%, in 0.9% Sodium Chloride, Preservative Free, Total Volume 3 mL in a syringe, Rx only, PharMEDium, Product code 2R3343.
Reason: Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
D-0091-2017 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, Product code 2R3441, NDC 61553-441-80
Reason: Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
D-0068-2017 October 19, 2016 Lake Forest, IL
Pharmedium Services, LLC
Class II Terminated
lidocaine HCl, 1%, 10 mg per mL (50 mg per 5 mL), 5 mL Total Volume in a syringe, Rx only, PharMEDium, Product code 2R3106.
Reason: Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
D-0062-2017 October 19, 2016 Lake Forest, IL
Pharmedium Services, LLC
Class II Terminated
morphine Sulfate, 2 mg per mL, in 0.9% Sodium Chloride, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2T6455.
Reason: Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
D-0081-2017 October 19, 2016 Lake Forest, IL
Pharmedium Services, LLC
Class II Terminated
lidocaine HCl 1%, 10 mg per mL (50 mg per 5 mL), Preservative Free, 5 mL Total Volume in a syringe, Rx only, PharMEDium, Product code 2R3391.
Reason: Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
D-0064-2017 October 19, 2016 Lake Forest, IL
Pharmedium Services, LLC
Class II Terminated
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
Reason: Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
D-0033-2017 October 19, 2016 Lake Forest, IL
Pharmedium Services, LLC
Class II Terminated
HEPARIN 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.
Reason: Subpotent Drug and Stability Data Does Not Support Expiry: confirmed subpotency and potential loss of potency in drugs packaged and stored in syringes.
D-0049-2017 October 19, 2016 Lake Forest, IL
Pharmedium Services, LLC
Class II Terminated
lidocaine HCl, 2%, Preservative Free, Total Volume 2mL, Product code 2R3323, NDC 61553-323-79
Reason: Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
D-0066-2017 October 19, 2016 Lake Forest, IL
Pharmedium Services, LLC
Class II Terminated
ketamine HCl, 10 mg per mL, 50 mg per 5 mL, 0.9% Sodium Chloride, 5 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3320.
Reason: Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
D-0054-2017 October 19, 2016 Lake Forest, IL
Pharmedium Services, LLC
Class II Terminated
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.
Reason: Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
D-0042-2017 October 19, 2016 Lake Forest, IL