Ranitidine Syrup (Ranitidine Oral Solution USP), 15 mg/mL, 150 mg/10 mL per cup, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio. (a) Case of 50 cups (NDC 60687-260-69) (b) Case of 40 cups (NDC 60687-260-23 (c) Unit Dose Cup (NDC 60687-260-69)
Reported: January 8, 2020 Initiated: November 1, 2019 #D-0631-2020
Product Description
Ranitidine Syrup (Ranitidine Oral Solution USP), 15 mg/mL, 150 mg/10 mL per cup, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio. (a) Case of 50 cups (NDC 60687-260-69) (b) Case of 40 cups (NDC 60687-260-23 (c) Unit Dose Cup (NDC 60687-260-69)
Reason for Recall
CGMP Deviations: Presence of NDMA impurity detected in product.
Details
- Recalling Firm
- American Health Packaging
- Units Affected
- 1,692 cases of 40 and 50 cups
- Distribution
- Nationwide USA
- Location
- Columbus, OH
Frequently Asked Questions
What product was recalled? ▼
Ranitidine Syrup (Ranitidine Oral Solution USP), 15 mg/mL, 150 mg/10 mL per cup, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio. (a) Case of 50 cups (NDC 60687-260-69) (b) Case of 40 cups (NDC 60687-260-23 (c) Unit Dose Cup (NDC 60687-260-69). Recalled by American Health Packaging. Units affected: 1,692 cases of 40 and 50 cups.
Why was this product recalled? ▼
CGMP Deviations: Presence of NDMA impurity detected in product.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on January 8, 2020. Severity: Moderate. Recall number: D-0631-2020.
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