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D-0373-2017 Class II Terminated

Recalled by Wells Pharmacy Network LLC — Ocala, FL

FDA drug recall D-0373-2017 was initiated by Wells Pharmacy Network LLC on September 21, 2016 and is designated Class II. Reason for recall: Lack of Assurance of Sterility The recall status is terminated (terminated July 2, 2021). Affected quantity: 4 vials.

Recall Details

Product Type: Drugs
Report Date: January 11, 2017
Initiation Date: September 21, 2016
Termination Date: July 2, 2021
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 4 vials

Product Description

MIC/B-COMP+LIDO 20 mg/40 mg/50 mg/10 mg/mL Injectable, 30 mL vial, Compounded by Wells Pharmacy, Ocala, FL

Reason for Recall

Lack of Assurance of Sterility

Distribution Pattern

Nationwide

Code Information

All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known lot code: 07132016@5.

Other recalls by Wells Pharmacy Network LLC

D-0331-2017 Class II — Phenylephrine HCl Injectable, 1 mg/mL (0.1%), 5 mL vial, Compounded by Wells Pha (September 21, 2016)
D-0351-2017 Class II — Chorionic Gonadotropin Lyophilized, 20,000 unit Injectable Kit, Compounded by We (September 21, 2016)
D-0421-2017 Class II — Vitamin D3 in Sesame Oil Injectable 50,000 IU/mL, 5 mL vial, Compounded by Wells (September 21, 2016)
D-0368-2017 Class II — MIC/B12(M) 15 mg/50 mg/100 mg/1 mg/mL Injectable, 30 mL vial, Compounded by Well (September 21, 2016)
D-0341-2017 Class II — Arginine/Citrulline/Ornit+Lido 100/100/100/10 mg/mL Injectable, 10 mL vials, Com (September 21, 2016)
D-0415-2017 Class II — Trimix Injectable 30 mg/1 mg/10 mcg/mL a) 2 mL and b) 5 mL and c) 10 mL vials, C (September 21, 2016)
D-0332-2017 Class II — MIC Combo - Standard 15 mg/50 mg/100 mg/mL Injectable, 30 mL vials, Compounded b (September 21, 2016)
D-0401-2017 Class II — Testosterone Cypionate in Grapeseed Oil Injectable, 20 mg/mL, 5 mL vial, Compoun (September 21, 2016)
D-0408-2017 Class II — Tri 2 (PAP/PHEN/ATROPINE) NR Injectable, 30 mg/3 mg/0.3 mg/mL, a) 2 mL and b) 5 (September 21, 2016)
D-0412-2017 Class II — Trimix Injectable 30 mg/2 mg/40 mcg, 5 mL vial, Compounded by Wells Pharmacy, Oc (September 21, 2016)