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.
- 2016-11-02FDA-DrugBoehringer Ingelheim Pharmaceuticals, Inc.Class IIPersantine (dipyridamole USP) tablets, 75 mg, 100-count bottles, Rx only, Dist. by: Boehringer Ingelheim (BI) Pharmaceuticals, Inc., Ridgefield, CT 06877, NDC 0597-0019-01
Presence of foreign tablets/capsules: 50 mg Persantine tablets were found in a 75 mg Persantine 100-count bottle and 50 mg Persantine tablet was found in a 100 count bottle of 75 mg Dipyridamole.
- 2016-10-26FDA-DrugSupernus Pharmaceuticals, Inc.Class IITrokendi XR (topiramate) extended-release capsule, 50mg, 30-count blister pack, Rx only, Manufactured by: Catalent Pharma Solutions, Winchester, KY 40391, Manufactured for: Supernus Pharmaceuticals, Inc., Rockville, MD 20850, NDC 17772-102-15
Superpotent Drug: Failure of assay specifications in the capsule.
- 2016-10-26FDA-DrugTeva Pharmaceuticals USAClass IIIPARICALCITOL Capsules, 4 mcg, 30-count bottles, Rx only, Manufactured By: Pharmaceutics International, Inc., Hunt Vallet, MD 21031; Manufactured For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0093-7658-56.
Failed Impurities/Degradation Specifications: out of specification test results for impurities during stability testing.
- 2016-10-26FDA-DrugTeva Pharmaceuticals USAClass IIIPARICALCITOL Capsules, 2 mcg, 30-count bottles, Rx only, Manufactured By: Pharmaceutics International, Inc., Hunt Vallet, MD 21031; Manufactured For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0093-7657-56.
Failed Impurities/Degradation Specifications: out of specification test results for impurities during stability testing.
- 2016-10-26FDA-DrugTeva Pharmaceuticals USAClass IIIPARICALCITOL Capsules, 1 mcg, 30-count bottles, Rx only, Manufactured By: Pharmaceutics International, Inc., Hunt Vallet, MD 21031; Manufactured For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0093-7656-56.
Failed Impurities/Degradation Specifications: out of specification test results for impurities during stability testing.
- 2016-10-26FDA-DrugDream Body Weight LossClass IIDream Body Advanced 400 mg 30 capsules in brown foil packets.
Marketed without an approved NDA/ANDA: Undeclared sibutramine.
- 2016-10-26FDA-DrugDream Body Weight LossClass IIDream Body 450 mg 30 capsules in a plastic screw on top bottle
Marketed without an approved NDA/ANDA: Undeclared sibutramine.
- 2016-10-26FDA-DrugDream Body Weight LossClass IIDream Body Extreme Gold 800 mg 30 capsules in a plastic screw on top bottle
Marketed without an approved NDA/ANDA: Undeclared sibutramine.
- 2016-10-26FDA-DrugArbor Pharmaceuticals Inc.Class ICetylev (acetylcysteine) effervescent tablets for oral solution, 500 mg, Rx Only, 20 tablets per carton (ten 2 count blister packs), Distributed by Arbor Pharmaceuticals, LLC Atlanta, GA 30328, NDC 24338-700-10.
Defective Container: Incomplete seal on blister packaging, leading to tablet swelling and enlarging due to effervescence process beginning as oxygen and moisture enter the blister packaging.
- 2016-10-26FDA-DrugSOS Telecom Inc.Class ISuper Samurai-X , 1000 mg, 1 capsule per pack , 24 single packs per box.
Marketed without an approved NDA/ANDA: FDA sample analyses revealed the presence of undeclared sildenafil and/or its analogs in products marketed as dietary supplements
- 2016-10-26FDA-DrugSOS Telecom Inc.Class IGinseng Power-X , 1800 mg, 1 capsule per pack , 24 single packs per box.
Marketed without an approved NDA/ANDA: FDA sample analyses revealed the presence of undeclared sildenafil and/or its analogs in products marketed as dietary supplements
- 2016-10-26FDA-DrugSOS Telecom Inc.Class INinja-X, 4200 mg, 1 capsule per pack, 24 single packs per box.
Marketed without an approved NDA/ANDA: FDA sample analyses revealed the presence of undeclared sildenafil and/or its analogs in products marketed as dietary supplements
- 2016-10-26FDA-DrugSOS Telecom Inc.Class ITiger-X, 1200 mg, 1 capsule per pack , 24 single packs per box
Marketed without an approved NDA/ANDA: FDA sample analyses revealed the presence of undeclared sildenafil and/or its analogs in products marketed as dietary supplements
- 2016-10-19FDA-DrugAllergan Sales, LLCClass IITAZORAC (tazarotene) Gel 0.05%, Rx only, packaged in 15 x 3.5 g professional sample containers, Manufactured by: Allergan Inc., Irvine, CA 92512. UPC: 300238335159.
Failed Content Uniformity Specifications
- 2016-10-19FDA-DrugAllergan Sales, LLCClass IITAZORAC (tazarotene) Gel 0.05%, Rx only, For Dermatologic Use Only, Not for Ophthalmic Use, packaged in a) 30 g tubes (NDC: 0023-8335-03, UPC: 300238335036) and b)100 g tubes,(NDC: 0023-8335-10, UPC: 300238335104), Manufactured by: Allergan Inc., Irvine, CA 92512.
Failed Content Uniformity Specifications
- 2016-10-19FDA-DrugDr. Reddy's Laboratories, Inc.Class IIIZENATANE (isotretinoin capsules USP) 20 mg, 30 capsules per prescription pack, Rx Only, Manufactured by: Cipla Limited, Kurkumbh Village Pune 4138012 India, Manufactured for: Dr. Reddy's Laboratories Limited Bachupally 500 090 India, NDC 55111-136-81
Failed Dissolution Specifications
- 2016-10-19FDA-DrugHospira Inc., A Pfizer CompanyClass IIMarcaine 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.
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 than the labeled potency.
- 2016-10-19FDA-DrugHospira Inc., A Pfizer CompanyClass IIMarcaine 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.
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 than the labeled potency.
- 2016-10-19FDA-DrugTeva Pharmaceuticals USAClass IIImitoXANTRONE Injection USP (concentrate), 20 mg/10 mL (2 mg/mL), 10 mL Multiple Dose Vial, Rx only, Teva Parenteral Medicines, Inc., Irvine, CA 92618, NDC 0703-4685-01.
Failed Impurities/Degradation Specifications: potential failure to meet the specification for Impurity D throughout shelf-life.
- 2016-10-19FDA-DrugB. Braun Medical IncClass I5% Dextrose Injection USP, 100mL in a 150 mL PAB container, Rx only, B. Braun Medical Inc. Irvine, CA 92614-5895 USA, NDC 00264-1510-32
Non-Sterility: fungal contamination due to leaking containers.
- 2016-10-19FDA-DrugPharmedium Services, LLCClass IfentaNYL 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.
Subpotent Drug: confirmed subpotency in one lot of this product that was packaged and stored in syringes.
- 2016-10-19FDA-DrugPharmedium Services, LLCClass IIlidocaine HCl, 2%, 20 mg per mL (100 mg per 5 mL), 5 mL Total Volume in a syringe, Rx only, PharMEDium, Product code 2R3110.
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
- 2016-10-19FDA-DrugPharmedium Services, LLCClass IIlidocaine HCl, 1%, in 0.9% Sodium Chloride, Preservative Free, Total Volume 3 mL in a syringe, Rx only, PharMEDium, Product code 2R3343.
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
- 2016-10-19FDA-DrugPharmedium Services, LLCClass IIsuccinylcholine 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.
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
- 2016-10-19FDA-DrugPharmedium Services, LLCClass IIrocuronium 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.
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
- 2016-10-19FDA-DrugPharmedium Services, LLCClass IIremifentanil 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.
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
- 2016-10-19FDA-DrugPharmedium Services, LLCClass IIPHENYLephrine HCl, 100 mcg per mL, 0.5 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 2R3346.
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
- 2016-10-19FDA-DrugPharmedium Services, LLCClass IIPHENYLephrine HCl, 100 mcg per mL, 0.5 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 2R3109.
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
- 2016-10-19FDA-DrugPharmedium Services, LLCClass IIPHENYLephrine HCl, 40 mcg per mL, 200 mcg 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 2R3376.
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
- 2016-10-19FDA-DrugPharmedium Services, LLCClass IIneostigmine Methylsulfate, 1 mg per mL, 3 mg per 3 mL, 3 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3551.
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
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