FDAClass IIIAugust 16, 2017

Glipizide Extended-Release Tablets recall

Glipizide Extended-Release Tablets (anti-diabetic agent), 5 mg, packaged in 30-unit dose blister pack per carton, Rx only, Mfd for: Watson Laboratories, Inc., Corona, CA 92880, Mfd by: Patheon Pharmaceuticals, Inc., Cincinnati, OH 43215, NDC 0591-0844-15

Why was Glipizide Extended-Release Tablets recalled?

Failed Moisture Limits: out of specification test results for water content obtained during stability testing.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot # 3138405A, Exp 8/2017

Product
Glipizide Extended-Release Tablets (anti-diabetic agent), 5 mg, packaged in 30-unit dose blister pack per carton, Rx only, Mfd for: Watson Laboratories, Inc., Corona, CA 92880, Mfd by: Patheon Pharmaceuticals, Inc., Cincinnati, OH 43215, NDC 0591-0844-15
Recalling firm
Teva Pharmaceuticals USA
Quantity
2,880 cartons (30 unit dose blister pack per carton)
Distribution
Product distributed to OH, IL, PA, MI, VA and CT
Recall date
August 16, 2017
Classification
Class III
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls