The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-1127-2018·Announced 2018-09-05

PD-Rx Pharmaceuticals Recalls Doxycycline Hyclate Tablets for Dissolution Failures

PD-Rx Pharmaceuticals is recalling Doxycycline Hyclate 100 mg tablets because the manufacturer reported failed dissolution specifications.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves failed dissolution specifications without reported injuries or illnesses, fitting the criteria for a moderate severity recall.

Plain-English summary

PD-Rx Pharmaceuticals, Inc. is recalling Doxycycline Hyclate USP Tablets, 100 mg, in various bottle sizes. The recall involves 6,641 bottles distributed nationwide in the USA. The product is a prescription-only oral medication.

The recall was initiated because the manufacturer, West-Ward Pharm Corp., reported that the repackaged lots failed dissolution specifications. Dissolution is a measure of how quickly a tablet breaks down and releases the active ingredient in the body. Failed dissolution results may affect the drug's performance.

Consumers and healthcare providers should stop using the affected lots and contact their pharmacist or healthcare provider for guidance. The affected lots are identified by specific lot numbers and expiration dates listed in the recall notice.

The recalled product

Product
DOXYCYCLINE (DOXYCYCLINE HYCLATE)
Brand
DOXYCYCLINE
Manufacturer
PD-Rx Pharmaceuticals, Inc.
Category
Drug — Antibiotic
Hazard
Affected units
6,641

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 (20)

  • Lot #: a) D17D29
  • L17C73
  • F18E73
  • Exp. 1/31/19
  • b) H17D70
  • K17F66
  • G18F26
  • c) C18G26
  • F18E36
  • d) F18A85
  • e) K17B44
  • K17E29
  • L17D93
  • E17B88
  • Exp. 5/31/19
  • H17A52
  • H17D67
  • Exp. 7/31/19
  • f) E17B01
  • E17E83

UPCs (1)

  • 0355289866954

Distribution

Distributed nationwide across the United States.

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