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FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE

Consumer Media: 888-Info-FDA
November 4, 1998

PRODUCT
Propranolol HCl Extended Release (ER) Capsules, distributed in 60 mg, 80 mg, 120 mg and 160 mg strengths, in 100 count bottles, Rx product indicated in the management of hypertension, under the following labels: Inwood, Qualitest, URL, Zenith, Teva, Geneva, and Brightstone Pharma. NDC numbers:

Inwood:       60 mg:  NDC # 0258-3609-01
              80 mg:   NDC # 0258-3610-01
             120 mg:  NDC # 0258-3611-01.
             160 mg:  NDC # 0258-3612-01
Qualitest:    80 mg:  NDC 0603-5498-21,
             120 mg:    NDC 0603-5499-21,
             160 mg:    NDC 0603-5500-21
United Research Laboratories (URL)
             80 mg:  NDC 0677-1364-01;
            120 mg:  NDC 0677-1365-01;
            160 mg:  NDC 0677-1366-01. 160 mg
Zenith Goldline Laboratories:
             60 mg:  NDC 0182-1926-01.
             80 mg:  NDC 0182-1927-01.
            120 mg:  NDC 0182-1928-01.
            160 mg:  NDC 0182-1929-01.
Teva (Lemmon) Pharmaceuticals USA
             60 mg:  NDC 0093-0691-01.
             80 mg:  NDC 0093-0692-01.
            120 mg:  NDC 0093-0693-01.
            160 mg:  NDC 0093-0694-01.
Geneva Pharmaceuticals, Inc.
            60 mg:  NDC 0781-2061-01.
            80 mg:  NDC 0781-2062-01.
           160 mg:  NDC 0781-2064-01.
Brightstone Pharma Inc.
            60 mg: NDC 62939-7112-1.
            80 mg: NDC 62939-7122-1.
           120 mg: NDC 62939-7132-1.
           160 mg: NDC 62939-7142-1.    Recall
#D-006/009-9.

CODE
Lot numbers (Expiration dates):
60 mg (10 lots): 7J031 (3/99), 7J033 (3/99), 8A042 (3/99),
                 7K014 (5/99), 7K015 (5/99), 7K016 (5/99),  
                 7K018 (1/99), 8A035 (1/99), 8A038 (1/99),   
                 8A040 (2/99).
80 mg (4 lots):  7F052 (9/99), 8A047 (1/99), 8A048 (2/99),
                 8A052 (11/99).
120 mg (4 lots): 7K027 (9/99), 8A053 (1/99), 8A054 (1/99),
                 8A055 (1/99).
160 mg (4 lots): 7J045 (9/99), 8A060 (1/99), 8A061 (1/99),
                 8A062 (2/99).

MANUFACTURER
Inwood Laboratories, In., a subsidiary of Forest Laboratories, Inc., Inwood, New York.

RECALLED BY
Manufacturer, by letter on October 6, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide and Puerto Rico.

QUANTITY
The following number of bottles were distributed:
60 mg :  33, 812
80 mg :  74, 247
120 mg:  35, 004
160 mg:  16, 752.

REASON
Dissolution failure.

 

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.