Home / Recalls / Advanced Pharma Inc. / D-0117-2018

D-0117-2018 Class II Terminated

Recalled by Advanced Pharma Inc. — Houston, TX

Recall Details

Product Type
Drugs
Report Date
December 27, 2017
Initiation Date
June 9, 2017
Termination Date
April 3, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
50 syringes

Product Description

NitroGlycerin 100 mcg/mL QS 5% Dextrose Inj, USP (2 mg per 20 mL) 20 mL Sterile single dose syringe, packaged in 10 x 5 (FIFTY) syringes per box, Rx only, Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054, NDC 15082-818-62.

Reason for Recall

Stability Data Does Not Support Expiry: lots do not have stability that supports the use of the container system.

Distribution Pattern

Nationwide in the USA to hospitals and medical facilities.

Code Information

Lot: 5/31/17 0202 5-81862S, BUD 7/30/17

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  • 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-1026-2019 Class II — 2% Lidocaine HCl Injectable Solution, 60 mg/3 mL (20 mg per mL), 3mL Sterile sin (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)
  • D-1019-2019 Class II — Midazolam Benzodiazepine 50 mg/50 mL (1 mg/mL) Injectable Solution, Midazolam HC (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-1016-2019 Class II — HYDROmorphone HCl 1 mg in 0.9% Sodium Chloride, QS 5 mL Injectable Solution 1 mg (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)