ED A-HIST TABLETS, Antihistamine, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: Edwards Pharmaceuticals Inc., Ripley, MS 38663, NDC 0485-0154-01

Recall Insight

This FDA Drug action (record #D-515-2013) was formally reported on June 12, 2013, with the manufacturer initiating the action on January 30, 2013. It is classified under Moderate severity (Class II), with a current status of Terminated. TG United, Inc. is listed as the recalling firm, operating out of Brooksville, FL. Federal records indicate 242,470 units are affected, a scale large enough to require multi-state distribution tracking.

The documented reason for this recall is: CGMP Deviations: Products are underdosed or have an incorrect dosage regime. Distribution data in the federal record shows the product reached: FL, MS, SC, LA and TX. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 5 were also issued by FDA Drug. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 13 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.