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D-1017-2019 Class II Terminated

Recalled by Advanced Pharma Inc. — Houston, TX

FDA drug recall D-1017-2019 was initiated by Advanced Pharma Inc. on March 13, 2019 and is designated Class II. Reason for recall: Lack of Assurance of Sterility The recall status is terminated (terminated January 14, 2020). Affected quantity: 360 bags.

Recall Details

Product Type: Drugs
Report Date: March 27, 2019
Initiation Date: March 13, 2019
Termination Date: January 14, 2020
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 360 bags

Product Description

fentaNYL 1000 mcg/100 mL Injectable Solution Fentanyl 0.9% Sodium Chloride, QS, 100 mL, Sterile single use bag, NDC: 42852-210-10 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404

Reason for Recall

Lack of Assurance of Sterility

Distribution Pattern

Nationwide

Code Information

Lot: 01/03/19 1311 21010P Exp. 5/3/2019

Other recalls by Advanced Pharma Inc.

D-1251-2019 Class II — HYDROmorphone 20 mg/100 mL Injectable Solution, Hydromorphone HCl 20 mg 0.9% Sod (April 26, 2019)
D-1028-2019 Class II — Phenylephrine HCl, 800 mcg in 0.9% Sodium Chloride, QS 10 mL Injectable Solution (March 13, 2019)
D-1031-2019 Class II — Heparin 5,000 Units/5mL (1,000 Units per mL) Injectable Solution, 5,000 Units in (March 13, 2019)
D-1019-2019 Class II — Midazolam Benzodiazepine 50 mg/50 mL (1 mg/mL) Injectable Solution, Midazolam HC (March 13, 2019)
D-1025-2019 Class II — Glycopyrrolate 0.6 mg/3 mL (0.2 mg per mL) Injectable Solution, 3 mL Sterile sin (March 13, 2019)
D-1026-2019 Class II — 2% Lidocaine HCl Injectable Solution, 60 mg/3 mL (20 mg per mL), 3mL Sterile sin (March 13, 2019)
D-1027-2019 Class II — 2% Lidocaine HCl Injectable Solution, 100 mg/5 mL (20 mg per mL), 5mL Sterile si (March 13, 2019)
D-1024-2019 Class II — Neostigmine Methylsulfate Injection Solution 5 mg/5mL (1 mg per mL), 5mL Sterile (March 13, 2019)
D-1029-2019 Class II — Esmolol HCl Injectable Solution 100 mg/10 mL (10 mg per mL)10mL Sterile single u (March 13, 2019)
D-1021-2019 Class II — Glycopyrrolate Injectable Solution 1 mg/5 mL (0.2 mg per mL), Sterile single use (March 13, 2019)