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FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE

Consumer Media: 888-Info-FDA
March 25, 1998

PRODUCT
Propranolol HCL Extended-release Capsules, indicated in the management of hypertension, Rx. Brand name BetachronTM, under the following labels: TEVA, URL, Shein, Parmed, Qualitest, Rugby, Geneva, Moore, Major, Zenith Goldline:
a) Propranolol HCL 60 mg Extended Release (ER) Capsules, 100 count bottles, NDC # 0258-3609-01;
b) Propranolol HCL 80 mg ER Capsules, 100 count bottles, NDC # 0258-3610-01.
c) Propranolol HCL 120 mg ER Capsules, 100 count bottles, NDC # 0258-3611-01.
d) Propranolol HCL 160 mg ER capsules, 100 count bottles, NDC # 0258-3612-01.

Recall #D-100/103-8.

CODE

60 mg strength: (20 lots)
6C083 (3/98), 6C085 (3/98), 6C087 (3/98), 6D001
(3/98), 6D003 (3/98), 6D005 (3/98), 6D007 (4/98),
6E004 (5/98), 6E005 (5/98), 6F022 (5/98), 6F023
(5/98), 6G001 (5/98), 6G003 (5/98), 6G004 (5/98),
6G005 (5/98), 6G006 (6/98), 6G019 (6/98), 6G020
(6/98), 6G021 (6/98) & 6G022 (6/98).
80 mg strength: (6 lots)
6D068 (3/98), 6E007 (4/98), 6E007A (4/98), 6F005
(7/98), 6F006 (7/98) & 6H011 (7/98).
120 mg strength: (9 lots)
6C089 (3/98), 6C090 (3/98), 6D069 (3/98), 6E008
(4/98), 6E008A (4/98), 6F007 (6/98), 6H015 (6/98),
6H016 (6/98) and 6F008 (6/98).
160 mg strength: (7 lots)
6C091 (3/98), 6C092 (4/98), 6E009 (4/98), 6E009A
(4/98), 6F009 (5/98), 6F010 (7/98), and 6H017
(7/98).
*** Additional 23 lots of 60 mg:
6K044 (4/98), 6K045 (4/98), 6L001 (4/98), 6L002
(4/98),6L003 (4/98), 6L004 (4/98), 6L005 (4/98),
6L006 (4/98), 6M033 (4/98), 6M036 (4/98), 6M035
(5/98), 6M037 (5/98), 6M038 (5/98), 7A062 (6/98),
7A065 (6/98), 7B004 (6/98), 7B005 (6/98), 7B006
(6/98), 7B007 (6/98), 7B008 (6/98), 7B022 (8/98),
7B025 (7/98) & 7D010 (11/98).
*** Additional 12 lots of 80 mg:
6H012 (7/98), 6J098 (8/98), 6J099 (9/98), 6K020
(9/98), 6K021 (10/98), 6K022 (11/98), 7A045
(12/98), 7A046 (1/99), 7A047 (1/99), 7C023 (2/99),
7D013 (3/99) & 7C025 (3/99).
*** Additional 11 lots of 120 mg:
6J100 (8/98), 6J101 (9/98), 6K023 (9/98), 6K024
(10/98), 6K025 (10/98), 6K026 (11/98), 7A050
(11/98), 7A051 (12/98), 7A052 (11/99), 7A053
(1/99) & 7C027 (2/99).
*** Additional 15 lots of 160 mg:
6H018 (8/98), 6H028 (8/98), 6J102 (8/98), 6J103
(8/98), 6K029 (10/98), 6K031 (10/98), 6K032
(10/98), 7A054 (11/98),7A055 (11/98), 7A056
(12/98), 7A057 (1/99), 7A058 (1/99), 7C031 (2/99),
7C032 (3/99) & 7F059 (5/99).

Updated to include:
29 additional lot numbers: D-100-8: Propranolol HCl 60 mg Extended Release (ER) Capsules, 100 count bottles, NDC # 0258-3609-01, 16 lots -- 7C003 (9/98), 7C004 (11/98), 7C005 (11/98), 7C017 (11/98), 7C018 (11/98), 7C019 (11/98), 7C021 (11/98), 7C022 (11/98), 7D007 (11/98), 7D008 (11/98), 7D009 (11/98), 7F042 (11/98), 7F043 (11/98), 7F044 (11/98), 7F045 (11/98) & 7F046 (11/98). D-101-8: Propranolol HCl 80 mg ER Capsules, 100 count bottles, NDC # 0258-3610-01. 4 lots - 7C024 (3/99), 7C026 (3/99), 7D014 (3/99) & 7F048 (5/99). D-102-8: Propranolol HCl 120 mg ER Capsules, 100 count bottles, NDC # 0258-3611-01, 6 lots - 7C028 (3/99), 7C029 (3/99), 7F053 (5/99), 7F054 (5/99), 7F056 (8/99) & 7F057 (8/99). D-103-8: Propranolol HCl 160 mg ER capsules, 100 count bottles, NDC # 0258-3612-01, 3 lots - 7C033 (3/99), 7F058 (5/99) & 7F060 (5/99).
Propranolol HCL, 60 mg, Extended Release (ER) Capsules, 60 mg, Lot numbers: 7H001, 7H002, 7H004 & 7H005; Propranolol HCL 80 mg, Extended Release (ER) Capsules, Lot number 7F050; Propranolol HCL, 120 mg, Extended Release (ER) Capsules, Lot number 7J041; Propranolol HCL, 160 mg, Extended Release (ER) Capsules, Lot numbers: 7F061, 7F063.
Propranolol HCL, 60 mg, Extended Release (ER) Capsules, 100 countbottles, 1 additional lot 7J032
Propranolol HCl 60 mg Extended Release (ER) Capsules, 100 count bottles, Lots 7F047, 7H003, 7K017, 8A043. Propranolol HCl 80 mg ER Capsules, 100 count bottles, Lot 7F049. Propranolol HCl 120 mg ER Capsules, 100 count bottles, None. Propranolol HCl 160 mg ER capsules, 100 count bottles, Lot 7F062.

MANUFACTURER
Inwood Laboratories, Inc., (a subsidiary of Forest Laboratories, Inc.), Inwood, New York.  Product was distributed under the following labels: Inwood, TEVA, URL, Schein, Parmed, Qualitest, Rugby, Geneva, Moore, Major,
and Zenith Goldline.

RECALLED BY

Manufacturer, by letter on March 4, 1998.
Firm-initiated recall ongoing.

DISTRIBUTION

Nationwide and Puerto Rico.

QUANTITY

294,016 bottles were distributed as follows:
Total 60 mg bottles distributed : 88,052
Total 80 mg bottles distributed : 90,220
Total 120 mg bottles distributed: 77,755
Total 160 mg bottles distributed: 37,989.

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.