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D-0955-2017 Class II Terminated

Recalled by Advanced Pharma Inc. — Houston, TX

FDA drug recall D-0955-2017 was initiated by Advanced Pharma Inc. on June 22, 2017 and is designated Class II. Reason for recall: Lack of Assurance of Sterility The recall status is terminated (terminated December 6, 2017).

Recall Details

Product Type: Drugs
Report Date: July 19, 2017
Initiation Date: June 22, 2017
Termination Date: December 6, 2017
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity

Product Description

Potassium Phosphate (USP) QS 0.9% Sodium Chloride (USP) 250 mL 30 mmol in NS 250mL Bag, Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404. NDC15082-924-25

Reason for Recall

Lack of Assurance of Sterility

Distribution Pattern

Nationwide with the United States

Code Information

Lot #: 5/31/17 1416 382-92425P BUD: 8/29/2017

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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)
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D-1024-2019 Class II — Neostigmine Methylsulfate Injection Solution 5 mg/5mL (1 mg per mL), 5mL Sterile (March 13, 2019)
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