RANITIDINE SYRUP (RANITIDINE ORAL SOLUTION, USP) 15 mg/mL (75 mg/5 mL), 473 mL (16 fl…

Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.

Recalling firm

Vintage Pharmaceuticals LLC, DBA Qualitest Pharmaceuticals

Origin

AL, United States

Initiated by

Voluntary: Firm initiated

FDA recall number

D-0162-2016

Other Ranitidine recalls

See all

Class II · Moderate risk Terminated Jan 15, 2020

Ranitidine 300 mg, 30 Tabs bottles, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 NDC 61919-455-30

Reason CGMP Deviations: Presence of NDMA impurity detected in product.

Direct Rx NDC 61919-455-30 D-0017-2021

Class II · Moderate risk Terminated Jan 15, 2020

Ranitidine 150 mg, a) 60 Tabs (NDC 61919-339-60); and b) 90 Tabs (NDC 61919-339-90) bottles, Rx only, Packaged and Distributed…

Reason CGMP Deviations: Presence of NDMA impurity detected in product.

Direct Rx NDC 61919-339-60 D-0016-2021

Class II · Moderate risk Terminated Jan 14, 2020

Ranitidine Hydrochloride (powder), USP, Rx only, Spectrum Chemical Mfg Corp., a) 1 gram, b) 5 grams, c) 25 grams, d)100 grams, e)…

Reason CGMP Deviations: Presence of NDMA impurity detected in product.

Spectrum Laboratory Products D-0825-2020

Class II · Moderate risk Terminated Jan 10, 2020

ranitidine hydrochloride, USP ,150 mg tablets a) 14-count bottles ( NDC 43063-844-14); b) 30-count bottles (NDC 43063-844-30)…

Reason CGMP Deviations: Received notice from supplier of potential -Nitrosodimethylamine (NDMA) amounts above established levels.

PD-Rx Pharmaceuticals, Inc. NDC 43063-844-14 D-0826-2020

Class II · Moderate risk Terminated Jan 7, 2020

Preferred Pharmaceuticals, Inc, Ranitidine Tablets, 300 mg, Rx Only, a) 14 count bottles (NDC: 68788-6382-1), b) 30 count bottles…

Reason CGMP Deviations: Presence of NDMA impurity detected in product.

Preferred Pharmaceuticals, Inc D-0797-2020