The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0482-2017·Announced 2017-03-01

RemedyRepack Recalls Glipizide Tablets for Failed Dissolution Specifications

RemedyRepack Inc. is recalling Glipizide 2.5 mg ER tablets because they failed to meet dissolution specifications. The product was distributed to a customer in Florida.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a 'Severe' rating under the rubric, particularly given the potential for significant health consequences if the medication does not dissolve properly.

Plain-English summary

RemedyRepack Inc. is recalling Glipizide 2.5 mg ER Tablets, NDC 52125-0764-02, due to failed dissolution specifications. The tablets were manufactured by Watson Laboratories, Inc., and repackaged by RemedyRepack Inc. The specific lot involved is B0129373-021916, with an expiration date of 10/17.

The recall is classified as FDA Class II. The product was distributed to a sold customer in Florida. The quantity involved is 630 pills, packaged as 21 bottles containing 30 pills each.

Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for guidance on alternative treatment options. The recall is being conducted to ensure the medication meets required quality standards for dissolution.

The recalled product

Product
Glipizide 2.5 mg ER Tablets, Manufactured by Watson Laboratories, Inc., Parsippany, NJ 07054, Repackaged by RemedyRepack, Indiana, PA 15701, NDC 52125-0764-02
Manufacturer
RemedyRepack Inc.
Category
Drug — Prescription Medication
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 (2)

  • Lot # B0129373-021916
  • Exp. 10/17 00591-0900-30 Original NDC 52125-0764-02 RemedyRepack NDC

Distribution

Distributed in 1 state:

Related recalls

Same manufacturer · RemedyRepack Inc.

See all →

Same hazard · failed dissolution

See all →

Similar recalls