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FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE
Consumer Media: 888-Info-FDA
May 5, 1999

Inwood Laboratories, Inc. Recalls Indomethacin Extended-Release Capsules

Inwood, NY (SafetyAlerts) - The Food and Drug Administration (FDA) today reported that Inwood Laboratories, Inc. is recalling Indomethacin Extended-Release Capsules because of dissolution failure (at stability testing).

PRODUCT
Indomethacin Extended-Release Capsules, USP, Indochron Capsules, 75 mg, in 60 and 100 unit bottles, a prescription non-steroidal, anti-inflammatory drug used in the treatment of rheumatoid arthritis, ankylosing spondylitis and osteoarthritis, under the following labels:

Inwood NDC 0258-3607-06 (60s) and NDC 0258-3607-01 (100s)
Teva Pharmaceuticals USA NDC: 0093-0628-06
United Research Laboratories (URL), 60s NDC: 0677-1197-06
Schein Pharmaceutical, 100s NDC: 0364-2211-01
Major Pharmaceuticals, 60s NDC: 0904-1178-52, 100s NDC: 0904-1178-60
Brightstone Pharma, 60s NDC: 62939-7012-7, 100s NDC: 62939-7012-1
Zenith Goldline Pharmaceuticals,(Goldline Labs)60s NDC: 0182-1469-26, 100s NDC: 0182-1469-01
Qualitest Products, 60s NDC: 0603-4070-20100s NDC: 0603-4070-21
Geneva Pharmaceuticals, 60s NDC: 0781-2153-60.

Recall #D-205-9.

CODE
All lot numbers remaining in expiry: Lot numbers (expiration date): 8A029 (3/1999), 8A031 (4/1999), 8A032 (4/1999), 8B028 (4/1999), 8A033 (6/1999), 8A034 (6/1999), 8B029 (6/1999),8D004 (7/1999), 8D005 (7/1999), 8D006 (8/1999), 8D007(8/1999), 8E027 (10/1999), 8E028 (10/1999), 8E029 (10/1999),8E030 (10/1999), 8G049 (12/1999), 8G050 (12/1999), 8G051(12/1999), 8G052 (12/1999), 8G053 (12/1999), 8G054 (1/2000),8G055 (1/2000), 8J080 (1/2000), 8J081 (1/2000), 8J082(2/2000), 8J084 (2/2000), 8J085 (2/2000), 8K030 (2/2000), 8K031 (2/2000), 8K032 (3/2000), 8K033 (3/2000), 8K034 (3/2000) and 8M022 (4/2000).

MANUFACTURER
Inwood Laboratories, Inc., Inwood, New York.

RECALLED BY
Manufacturer, by letters dated March 30, 1999, and April 6, 1999. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide and Puerto Rico.

QUANTITY1
97,328 60-count bottles and 205,580 100-count bottles were distributed; firm estimated that 60,000 bottles (60s) and 62,000 bottles (100s) remained on market at time of recall initiation.

 

The information contained herein has been obtained from sources that the Company believes to be reliable, however, the Company has not independently verified or confirmed the information and the recipient acknowledges that no representations or warranties are being made in connection with the use of the information.