BLACK GOLD X ADVANCED capsules, 60-count bottles, Manufactured for: Making it A Lifestyle, L.L.C.
Making It a Lifestyle
Class I - Dangerous
Marketed without an approved NDA/ANDA - presence of undeclared sibutramine.
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Prescription Drugs
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Hyoscyamine Sulfate, Orally Disintegrating Tablets, 0.125 mg, 100-count bottles, Rx only, Manufactured for: Virtus Pharmaceuticals OPCO II, LLC., Nashville, TN 37217, NDC 76439-307-10.
VIRTUS PHARMACEUTICALS OPCO II L
Class I - Dangerous
Failed Content Uniformity Specifications: resulting in both superpotent and subpotent tablets.
Duloxetine Delayed-release Capsules USP 30 mg 30-count bottles, Rx Only, Manufactured by: Inventia Healthcare Private Limited Additional Ambermath M.I.D.C., Ambermath (East) 421506, INDIA, Distributed by: Cipia USA, Inc., Miami, FL 33156, NDC 69097-298-02
Inventia Healthcare Private Limited
Class I - Dangerous
Failed Tablet/Capsule Specifications: Capsule shell (s) opening inside the bottle The Initial reports stated one or two capsules in a bottle count of 30s opening. First report came in June 14, 2016. Till date about 22 reports have come in from pharmacies which report two batches 130/16/001 and 130/16/002. Third batch 130/16/003 is not distributed yet, will be recalled from warehouse.
3rd DEGREE capsules, 60-count bottles, Manufactured for: Making it A Lifestyle, L.L.C.
Making It a Lifestyle
Class I - Dangerous
Marketed without an approved NDA/ANDA - presence of undeclared sibutramine.
Bupivacaine Hydrochloride Inj., USP (2.5 mg/mL) 0.25%, packaged in 30 mL Single-dose Preservative-Free vials, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1159-02
Hospira Inc., A Pfizer Company
Class I - Dangerous
Presence of particulate matter: Confirmed customer report for the presence of particulate matter within a single vial.
C-PAV/PHENTOL/PGE1, All strengths, All sizes, Rx only, Colonia Care Pharmacy, Colonia NJ 07067
Colonia Care Pharmacy
Class I - Dangerous
Lack of Assurance of Sterility; sterility concerns with all injectable drug products that were made with sterilized filtered stock solutions.
Hyoscyamine Sulfate, Sublingual Tablets, 0.125 mg, 100-count bottle, Rx only, Manufactured for: Virtus Pharmaceuticals OPCO II, LLC., Nashville, TN 37217, NDC 76439-309-10.
VIRTUS PHARMACEUTICALS OPCO II L
Class I - Dangerous
Failed Content Uniformity Specifications: resulting in both superpotent and subpotent tablets.
Class I - Dangerous
Lack of Assurance of Sterility: confirmed customer complaints of leaking bags.
Class I - Dangerous
Microbial Contamination of Non-Sterile Products; microbial contamination with B. cepacia
BLACK LABEL X capsules, 60-count bottles, Manufactured for: Making it A Lifestyle, L.L.C.
Making It a Lifestyle
Class I - Dangerous
Marketed without an approved NDA/ANDA - presence of undeclared sildenafil.
Sermorelin/GHRP-6 Injection 6 mg-3 mg Lyophylized I, 2 mL vial, Rx, Town and Country Compounding and Consultation Services, Ridgewood, NJ 074502
Town and Country Compounding and Consultation Services
Class I - Dangerous
Non-Sterility; microbial contamination identified as Bacillus circulans
Hyoscyamine Sulfate, USP Tablets, 0.125 mg, 100-count tablets per bottle, Rx only, Manufactured for: Virtus Pharmaceuticals OPCO II, LLC., Nashville, TN 37217, NDC 76439-308-10.
VIRTUS PHARMACEUTICALS OPCO II L
Class I - Dangerous
Failed Content Uniformity Specifications: resulting in both superpotent and subpotent tablets.
Lidocaine HCL/ Sodium Bicarb, 1%/0.5% 0.5 mL SYR PF, packaged in a 3 cc pre-filled syringe, Rx only
Guardian Pharmacy Services
Class I - Dangerous
Non-Sterility: failed sterility test result.
Lidocaine HCl 1%, 10 mL Syringe, Hospital/Office Use Only, Rx Only, Cantrell Drug Co. 7321 Cantrell Rd. Little Rock, AR 72207
Cantrell Drug Company
Class I - Dangerous
Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
Class I - Dangerous
Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
Calcium Chloride, (1 g/10 mL) Injection Solution 10 mL, 10% Single-Dose Vial, Rx Only, Cantrell Drug Co. 7321 Cantrell Road Little Rock, AR 72207
Cantrell Drug Company
Class I - Dangerous
Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
HYDROmorphone HCl 50 mg/50 mL in 0.9% Sodium Chloride (1 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Co. 7321 Cantrell Road Little Rock, AR 72207, NDC 52533-006-04
Cantrell Drug Company
Class I - Dangerous
Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
Fentanyl Citrate 2,500 mcg in 0.9% Sodium Chloride (10 mcg/mL) 250 mL* Bag, Single-Dose Bag, Rx Only, Cantrell Drug Company 7321 Cantrell Road Little Road, AR 72207, NDC 52533-024-61
Cantrell Drug Company
Class I - Dangerous
Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
Class I - Dangerous
Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
Methylprednisolone Tablets, USP, 16 mg, 50-count bottles, Rx only, Manufactured by Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, NDC 59746-003-14.
Jubilant Cadista Pharmaceuticals
Class I - Dangerous
Labeling: Incorrect or Missing Lot and/or Exp Date: incorrect expiration date of 02/0218 is printed on the container label instead of the correct expiration date of 02/2018.