Drug and pharmaceutical recalls
17732 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2015-09-30FDA-DrugPharmedium Services, LLCClass IPHENYLephrine HCl, 10 mg added to 250 mL 0.9% Sodium Chloride Injection USP (40 mcg per mL), packaged in 250 ml bags, Rx only, PharMEDium Services, LLC, 12620 W. Airport Blvd., Sugar Land, TX 77478, NDC# 61553-149-50
Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride, USP injection which were subsequently recalled due to the presence of particulate matter (human hair).
- 2015-09-30FDA-DrugPharmedium Services, LLCClass IPHENYLephrine HCl, 60 mg added to 250 mL 0.9% Sodium Chloride Injection USP (240 mcg per mL), packaged in 250 ml bags, Rx only, PharMEDium Services, LLC, 12620 W. Airport Blvd., Sugar Land, TX 77478, NDC# 61553-236-50
Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride, USP injection which were subsequently recalled due to the presence of particulate matter (human hair).
- 2015-09-30FDA-DrugPharmedium Services, LLCClass IPHENYLephrine HCl, 20 mg added to 250 mL 0.9% Sodium Chloride Injection USP (80 mcg per mL), packaged in 250 ml bags, Rx only, PharMEDium Services, LLC, 12620 W. Airport Blvd., Sugar Land, TX 77478, NDC# 61553-156-50
Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride, USP injection which were subsequently recalled due to the presence of particulate matter (human hair).
- 2015-09-30FDA-DrugPharmedium Services, LLCClass IFentanyl Citrate, 5 mcg per mL (1,250 mcg per 250 mL), 250 mL total volume in a 250 mL LifeCare bag in Sodium Chloride 0.9%, IV Use Only, Rx only, PharMEDium Services, LLC, 6100 Global Drive, Memphis, TN 36141, NDC# 61553-107-50
Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride, USP injection which were subsequently recalled due to the presence of particulate matter (human hair).
- 2015-09-30FDA-DrugPharmedium Services, LLCClass IMorphine Sulfate, 1 mg per mL (250 mg per 250 mL), 250 mL total volume in a 250 mL LifeCare bag in Sodium Chloride 0.9%, IV Use Only, Rx only, PharMEDium Services, LLC, 6100 Global Drive, Memphis, TN 36141, NDC# 61553-181-50
Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride, USP injection which were subsequently recalled due to the presence of particulate matter (human hair).
- 2015-09-30FDA-DrugPharmedium Services, LLCClass IBupivacaine HCl 0.0625%, 250 mL total volume in a 250 mL LifeCare Bag in Sodium chloride 0.9%, Epidural Use Only, Rx Only, PharMEDium Services, LLC, 6100 Global Drive, Memphis, TN 36141, NDC# 61553-197-50
Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride, USP injection which were subsequently recalled due to the presence of particulate matter (human hair).
- 2015-09-30FDA-DrugPharmedium Services, LLCClass IPHENYLephrine HCl, 40 mg added to 250 mL 0.9% Sodium Chloride Injection USP (160 mcg per mL), packaged in 250 ml bags, Rx only, PharMEDium Services, LLC, 12620 W. Airport Blvd., Sugar Land, TX 77478, NDC# 61553-169-50
Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride, USP injection which were subsequently recalled due to the presence of particulate matter (human hair).
- 2015-09-30FDA-DrugPharmedium Services, LLCClass IPHENYLephrine HCl, 50 mg added to 250 mL 0.9% Sodium Chloride Injection USP (200 mcg per mL), packaged in 250 ml bags, Rx only, PharMEDium Services, LLC, 12620 W. Airport Blvd., Sugar Land, TX 77478, NDC# 61553-171-50
Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride, USP injection which were subsequently recalled due to the presence of particulate matter (human hair).
- 2015-09-30FDA-DrugAllergan Sales, LLCClass IIBLEPHAMIDE (sulfacetamide sodium and prednisolone acetate ophthalmic ointment, USP) 10 %/0.2 %, 3.5 g tube, Rx only, ALLERGAN, Irvine, California 92612, NDC 0023-0313-04, UPC 3 00230 31304 9.
Presence of Particulate Matter: Due to customer complaints of small black particles, identified as part of the ointment tube cap, generated by the action of unscrewing the cap from the aluminum tube and potentially introducing the particle into the product.
- 2015-09-30FDA-DrugAllergan Sales, LLCClass IIFML (fluorometholone ophthalmic ointment) 0.1%, 3.5 g tube, Rx only, Allergan, Inc., Irvine, CA 92612, NDC 0023-0316-04, UPC 3 0023-0316-04 0.
Presence of Particulate Matter: Due to customer complaints of small black particles, identified as part of the ointment tube cap, generated by the action of unscrewing the cap from the aluminum tube and potentially introducing the particle into the product.
- 2015-09-30FDA-DrugAllergan Sales, LLCClass IIRefresh P.M. (Mineral Oil 42.5% and White Petrolatum 57.3%) Lubricant Eye Ointment, Net wt. 0.12 oz (3.5 g) tube, Allergan, Inc., 2525 Dupont Drive, Irvine, CA 92612, NDC 0023-0240-04, UPC 3 00230 66704 3.
Presence of Particulate Matter: Due to customer complaints of small black particles, identified as part of the ointment tube cap, generated by the action of unscrewing the cap from the aluminum tube and potentially introducing the particle into the product.
- 2015-09-30FDA-DrugAllergan Sales, LLCClass IIRefresh Lacri-Lube (Mineral Oil 42.5% and White Petrolatum 56.8%) Lubricant Eye Ointment, packaged in a) Net wt. 0.12 oz (3.5 g) tubes (NDC 0023-0312-04) UPC 3 0023-0312-04 2 and b) Net wt. 0.25 oz (7 g) tubes (NDC 0023-0312-07) UPC 3 0023-0312-07 3, Allergan, Inc., 2525 Dupont Drive, Irvine, CA 92612.
Presence of Particulate Matter: Due to customer complaints of small black particles, identified as part of the ointment tube cap, generated by the action of unscrewing the cap from the aluminum tube and potentially introducing the particle into the product.
- 2015-09-30FDA-DrugBaxter Healthcare CorporationClass II0.9% Sodium Chloride Injection, USP, 100 mL MINI-BAG VIAFLEX Container, Single Dose Container, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015, USA, NDC 0338-0049-38
Lack of Assurance of Sterility: Recalling firm reported a complaint for mold on the interior surface of the overpouch.
- 2015-09-30FDA-DrugHospira, Inc.Class II1% Lidocaine HCl Injection, USP, 10 mg/mL, 30 mL Vial, Single-dose Preservative Free, Rx only, Hospira, Inc., Lake Forest, IL 60045, USA, NDC 0409-4279-02
Presence of Particulate Matter: particulate matter identified as iron oxide, was found embedded in the neck of glass vials.
- 2015-09-23FDA-DrugApotex Inc.Class IICevimeline Hydrochloride Capsules, 30 mg a) 100 count bottle, and b) 500 count bottle, Rx Only, Manufactured by: Apotex Research Pvt., Ltd., Bangalore, India, Manufactured for: Apotex Corp, Westin, FL, a) NDC 60505-3145-1, b) NDC 60505-3145-5
Failed Stability Specifications: product may not meet specification limit for assay test.
- 2015-09-23FDA-DrugEMD Serono, Inc.Class IIIClomiPHENE CITRATE Tablets, USP, 50 mg, 10-count (2 foil sealed plastic trays of 5 tablets each) per carton, Rx only, Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD., Jerusalem, 91010, Israel; Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960; NDC 0093-0041-03, UPC 3 0093-0041-03 7.
Chemical Contamination: impurity failure due to chemical contamination of the active ingredient.
- 2015-09-23FDA-DrugThe Compounding Pharmacy of AmericaClass IITri-Mix T-50/PGE 2/LIDO 2 0.09/0.32/0.04 Injectable, The Compounding Pharmacy of America, Knoxville, TN
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
- 2015-09-23FDA-DrugThe Compounding Pharmacy of AmericaClass IITri-Mix T-50/PGE 2/LIDO 2 0.03/0.18/0.09 Injectable, The Compounding Pharmacy of America, Knoxville, TN
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
- 2015-09-23FDA-DrugThe Compounding Pharmacy of AmericaClass IITri-Mix T-50/PGE 1 0.14/0.08 Injectable, The Compounding Pharmacy of America, Knoxville, TN
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
- 2015-09-23FDA-DrugThe Compounding Pharmacy of AmericaClass IITri-Mix T-50 8.8 mg/0.29 mg/2.9 mcg Injectable, The Compounding Pharmacy of America, Knoxville, TN
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
- 2015-09-23FDA-DrugThe Compounding Pharmacy of AmericaClass IITri-Mix T-106/PGE 2 0.1/0.14 Injectable, The Compounding Pharmacy of America, Knoxville, TN
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
- 2015-09-23FDA-DrugThe Compounding Pharmacy of AmericaClass IITri-Mix T-106 (30 mg/1 mg/25 mcg) Injectable,The Compounding Pharmacy of America, Knoxville, TN
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
- 2015-09-23FDA-DrugThe Compounding Pharmacy of AmericaClass IITri-Mix T-105 (30 mg/1 mg/10 mcg) Injectable, The Compounding Pharmacy of America, Knoxville, TN
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
- 2015-09-23FDA-DrugThe Compounding Pharmacy of AmericaClass IITri-Mix T-102/PGE 2/LIDO 2 0.06/0.3/0.2 Injectable, The Compounding Pharmacy of America, Knoxville, TN
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
- 2015-09-23FDA-DrugThe Compounding Pharmacy of AmericaClass IITri-Mix T-102 (17.65 mg/0.59 mg/10 mcg) Injectable, The Compounding Pharmacy of America, Knoxville, TN
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
- 2015-09-23FDA-DrugThe Compounding Pharmacy of AmericaClass IITri-Mix T-101 (17.65 mg/0.59 mg/5.9 mcg) Injectable, The Compounding Pharmacy of America, Knoxville, TN
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
- 2015-09-23FDA-DrugThe Compounding Pharmacy of AmericaClass IITri-Mix SUPER (28 mg/0.9 mg/37 mcg) Injectable, Sterile Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
- 2015-09-23FDA-DrugThe Compounding Pharmacy of AmericaClass IITri-Mix ST9E (60 mg/4 mg/150 mcg) Injectable, Sterile Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
- 2015-09-23FDA-DrugThe Compounding Pharmacy of AmericaClass IITri-Mix ST9C (30 mg/2 mg/120 mcg) Injectable, The Compounding Pharmacy of America, Knoxville, TN
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
- 2015-09-23FDA-DrugThe Compounding Pharmacy of AmericaClass IITri-Mix ST9A (30 mg/2 mg/80 mcg) Injectable, The Compounding Pharmacy of America, Knoxville, TN
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
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