D-0842-2018 Class II Terminated
FDA drug recall D-0842-2018 was initiated by RIJ Pharmaceutical LLC on May 7, 2018 and is designated Class II. Reason for recall: CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample. The recall status is terminated (terminated April 7, 2023). Affected quantity: 5043 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- June 20, 2018
- Initiation Date
- May 7, 2018
- Termination Date
- April 7, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5043 bottles
Product Description
Preferred Plus Pharmacy Antacid Extra Strength (Aluminum Hydroxide 400mg, Magnesium Hydroxide 400mg, Simethicone 40 mg), packaged in 12 FL. OZ. (355 mL), Manufactured By: RIJ Pharmaceutical Corp.40 Commercial Avenue, Middletown, NY 10941, Distributed by: Kinray Inc. Whitestone, NY 11357 NDC 53807-158-12, UPC 353807158123
Reason for Recall
CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
Distribution Pattern
Nationwide in the USA
Code Information
Lot #: 707007, Exp. 07/19