The Recall Desk
HighFDA (Drugs)·D-1455-2022·Announced 2022-08-31

QP Sudfedrine PE Max Strength tablets recalled for improper storage

Family Dollar Stores is recalling QP Sudfedrine PE Max Strength tablets nationwide due to storage temperature deviations that may have compromised product quality.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA classified this as a Class II recall due to CGMP storage temperature deviations. Although no illnesses or injuries have been reported, temperature excursions can compromise drug stability and efficacy, representing a potential health risk.

Plain-English summary

Family Dollar Stores, Llc. is recalling QP Sudfedrine PE Max Strength tablets (24-count, SKU 916001) that were distributed to specific Family Dollar Stores locations nationwide between April 30, 2022 and June 10, 2022.

The recall was issued because the product was held outside appropriate storage temperature conditions, constituting a deviation from Current Good Manufacturing Practice (CGMP) standards. Proper temperature control is essential for maintaining pharmaceutical product stability and safety.

This recall was classified as FDA Class II, reflecting the agency's assessment of the potential health impact associated with CGMP storage deviations.

The recalled product

Product
QP SUDFEDRINE PE MAX STRENGTH TBLT 24 CT distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
Manufacturer
Family Dollar Stores, Llc.
Category
Drug
Hazard
  • temperature-deviation
  • cgmp-violation

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • SKU: 916001

Distribution

Distributed nationwide across the United States.

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