The Recall Desk
Agency classClass IIIOur severity:LowFDA (Drugs)·D-389-2014·Announced 2014-01-01

Hi-Tech Pharmacal Recalls Acyclovir Oral Suspension for Stability Failures

Hi-Tech Pharmacal is recalling Acyclovir Oral Suspension because the product's viscosity and pH levels fell below required specifications.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 1/5 (Low).

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The FDA classified this as a Class III recall, which by definition is unlikely to cause adverse health consequences, fitting the 'Low' severity criteria for documentation or minor specification issues.

Plain-English summary

Hi-Tech Pharmacal Co., Inc. is recalling Acyclovir Oral Suspension, USP 200 mg/5 mL, Net Wt. 16 fl oz (473 mL). The recall involves 51.948 bottles of the prescription medication, which was distributed nationwide. The affected product is identified by NDC 50383-810-16 and includes specific batch numbers with expiration dates ranging from December 2013 to July 2014.

The recall was initiated because the product failed stability specifications, specifically regarding viscosity and pH levels being below the required standards. The U.S. Food and Drug Administration has classified this recall as Class III, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences.

Consumers and healthcare providers should stop using the recalled product and return it to the pharmacy or point of purchase for a refund or replacement. Patients should consult their healthcare provider for alternative treatment options if necessary.

The recalled product

Product
Acyclovir Oral Suspension, USP 200 mg/5 mL, Net Wt. 16 fl oz (473 mL), Rx only, Hi-Tech Pharmacal Co, Inc. Amityville, NY 11701. NDC 50383-810-16.
Manufacturer
Hi-Tech Pharmacal Co., Inc.
Category
Drug — Antiviral
Hazard

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 (7)

  • Batch no: 1) 614463 (exp. 03/2014)
  • 2) 612905 (exp. 12/2013)
  • 3) 614923 (exp. 03/2014)
  • 4) 615852 (exp. 05/2014)
  • 5) 615855 (exp. 05/2014)
  • 6) 616689 (exp. 07/2014)
  • 7) 616692 (exp. 07/2014).

Distribution

Distributed nationwide across the United States.

Related recalls

Same manufacturer · Hi-Tech Pharmacal Co., Inc.

See all →

Same hazard · stability failure

See all →

Similar recalls