Multi-event May 2019 FDA Recall Anastrozole by Zydus Pharmaceuticals Usa Inc

This Multi-event Class II drug recall was voluntarily initiated by Zydus Pharmaceuticals Usa Inc on May 6, 2019 for the product Anastrozole. The FDA reported the reason for recall as cgmp deviations. The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

Recall Number: D-1441-2019

Reason for Recall
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Initiated
05-06-2019
Reported
06-26-2019
Quantity
768 1000-count bottles

Recall Profile & Regulatory Data

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
Zydus Pharmaceuticals USA Inc
Nationwide in the USA
Anastrozole Tablets, USP, 1 mg, 1,000-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals (USA) Inc. Pennington, NJ 08534. NDC 68382-209-10

Batch or Lot Expiration Information

Lot# Lot EXP Date: M708570 Jun-19, M711270 Sep-19, M802207 Feb-20, M812460 Aug-20

Affected Packages Involved in this Recall

Recall Number: D-1440-2019

Reason for Recall
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Initiated
05-06-2019
Reported
06-26-2019
Quantity
1,425,264 30-count bottles

Recall Profile & Regulatory Data

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
Zydus Pharmaceuticals USA Inc
Nationwide in the USA
ANASTROZOLE Tablets, 1 mg, Rx Only, 30-count bottle, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India. Distributed by: Zydus Pharmaceuticals (USA) Inc. Pennington, NJ 08534 NDC 68382-209-06

Batch or Lot Expiration Information

Lot# Lot: M706674, M706676, M707685 EXP Jun-19; M711219, M711220, M711221, M711222, M711269, EXP Sep-19; M801027, EXP Dec-19; M801028, M801029, M801030, EXP Jan-20; M802206, EXP Feb-20, M805195, M805196, M805197, EXP Mar-20; M805199, M805202, M805944, M805945, M805948, M805951, M805953, M805956, M805957, M805958, M805959 Apr-20; M812457, EXP Jul-20, M812458, M812459, M813912, M813913, M813914, M813915, M813916, EXP Aug-20; M815768, M815769, M818274, EXP Oct-20; M818119, M818120, M818121, M818635, EXP Nov-20; M819270, M819861, M819862, EXP Dec-20; M900921, M900922, M900923, M900924, M900925, EXP Jan-21; M902634, M902635, EXP Feb-21.

Affected Packages Involved in this Recall

Recall Number: D-1446-2019

Reason for Recall
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Initiated
05-06-2019
Reported
06-26-2019
Quantity
168,330 90-count bottles

Recall Profile & Regulatory Data

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
Zydus Pharmaceuticals USA Inc
Nationwide in the USA
Pramipexole Dihydrochloride Tablets 0.5 mg, 90-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534. NDC 68382-198-16

Batch or Lot Expiration Information

Lot# Lots:M713431, M713432, M714172, EXP Sep-19; M714173, Oct-19; M800552, M800553, M800554, M800555 M800556 EXP Dec-19; M811135 M812818 M812819 M812820 M812821 EXP Jun-20, M815777 M815778 M815779 M815780 M815781 EXP Aug-20; M901927 M901929 M901931 M901933 M902089 EXP Jan-21

Recall Number: D-1442-2019

Reason for Recall
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Initiated
05-06-2019
Reported
06-26-2019
Quantity
204 1000-count bottles

Recall Profile & Regulatory Data

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
Zydus Pharmaceuticals USA Inc
Nationwide in the USA
Pramipexole Dihydrochloride Tablets 0.125 mg, 1,000-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534. NDC 68382-196-10

Batch or Lot Expiration Information

Lot# Lot: M714919, EXP Dec-19, M815081, EXP Aug-20, M900475, EXP Dec-20

Recall Number: D-1444-2019

Reason for Recall
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Initiated
05-06-2019
Reported
06-26-2019
Quantity
215,760 90-count bottles

Recall Profile & Regulatory Data

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
Zydus Pharmaceuticals USA Inc
Nationwide in the USA
Pramipexole Dihydrochoride Tablets 0.25 mg, 90-count bottle, Rx Only, Manufactured by: Cadila Healthcare Ltd Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534. NDC 68382-197-16

Batch or Lot Expiration Information

Lot# Lots: M706802, M706804, M706907, M706909, M707028, EXP May-19; M714180, M714181, EXP Oct-19; M717063, M717064, M801705, M801706, M801707, M801708, M714923, M714924, M714925 EXP Dec-19; M808307, M808308, M808309, M808310, EXP May-20; M812479, M812481, M812482, M812483, EXP Jul-20; M815787 M815789, M815790, M815791, M815788, EXP Sep-20; M820266, M820267, M820268, M820269, M820265 EXP Nov-20; M903040, M903041, M903042 EXP Jan-21.

Recall Number: D-1443-2019

Reason for Recall
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Initiated
05-06-2019
Reported
06-26-2019
Quantity
143,184 90-count bottles

Recall Profile & Regulatory Data

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
Zydus Pharmaceuticals USA Inc
Nationwide in the USA
Pramipexole DihydrochlorideTablets 0.125 mg, 90-count bottle, Rx Only, Manufactured by: Cadila Healthcare Ltd Ahmedabad, India. Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534. NDC 68382-196-16

Batch or Lot Expiration Information

Lot# Lot: M714176, M714177, EXP Oct-19; M714917, EXP Nov-19; M714918, M715594, M715595, EXP Dec-19; M802190, EXP Jan-20; M802191, EXP Feb-20, M808673, EXP May-20; M811125, M811126, M811127, M811128, M811129, EXP Jun-20; M815082, M815083, M815084, M815085, M815086 EXP Aug-20; M900476, M900477, M900478, M900479, M900481, Dec-20

Recall Number: D-1452-2019

Reason for Recall
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Initiated
05-06-2019
Reported
06-26-2019
Quantity
47,664 90-count bottles

Recall Profile & Regulatory Data

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
Zydus Pharmaceuticals USA Inc
Nationwide in the USA
Pramipexole Dihydrochloride Tablets 1.5 mg 90-count bottle, Rx only Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ NDC 68382-200-16

Batch or Lot Expiration Information

Lot# Lots: M713435 M713436 EXP Sep-19; M714191 EXP Oct-19; M808185 M808184 M808186 EXP May-20; M817634 M817635 EXP Nov-20

Recall Number: D-1445-2019

Reason for Recall
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Initiated
05-06-2019
Reported
06-26-2019
Quantity
3,156 1000-count bottles

Recall Profile & Regulatory Data

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
Zydus Pharmaceuticals USA Inc
Nationwide in the USA
Pramipexole Dihydrochloride Tablets 0.25 mg, 1000-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India. NDC 68382-197-10

Batch or Lot Expiration Information

Lot# Lots: M706803, EXP Jun-19; M713438, EXP Oct-19; M801704, EXP Jan-20; M808306, EXP Jun-20; M812484, EXP Aug-20; M820264, EXP Dec-20

Recall Number: D-1453-2019

Reason for Recall
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Initiated
05-06-2019
Reported
06-26-2019
Quantity
40872 25-count bottles

Recall Profile & Regulatory Data

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
Zydus Pharmaceuticals USA Inc
Nationwide in the USA
MethylPREDNISolone Tablets, USP 8 mg, 25 tablets, Rx Only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India NDC 68382-917-11

Batch or Lot Expiration Information

Lot# Lots: M713224, M713225, M713226, EXP Nov-19; M814746 EXP Sep-20; M816148 EXP Oct-20; M901600, M901601 EXP Feb-21

Recall Number: D-1451-2019

Reason for Recall
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Initiated
05-06-2019
Reported
06-26-2019
Quantity
13,564 25-count bottles

Recall Profile & Regulatory Data

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
Zydus Pharmaceuticals USA Inc
Nationwide in the USA
MethylPREDNISolone Tablets, USP 32 mg, 25 tablets, Rx Only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India NDC 68382-919-11

Batch or Lot Expiration Information

Lot# Lots: M713043, M713047, EXP Dec-19; M713045, EXP Nov- 19; M816143, EXP Oct-20.

Recall Number: D-1447-2019

Reason for Recall
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Initiated
05-06-2019
Reported
06-26-2019
Quantity
113,304 90-count bottles

Recall Profile & Regulatory Data

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
Zydus Pharmaceuticals USA Inc
Nationwide in the USA
Pramipexole Dihydrochloride Tablets 1 mg, 90-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534. NDC 68382-199-16

Batch or Lot Expiration Information

Lot# Lots: M714186 M714187 M714188 EXP Oct-19; M714903 M714904 M714905 M715586 M715587 EXP Nov-19; M801441 M801442 M801443 M801444 M801445 EXP Dec-19; M811152 M811153 M811154 M811155 M811156 M814298 EXP Jul-20; M814299 M814300 M814301 M814302 EXP Aug-20; M818136 M818137 M818138 M818139 M818140 EXP Nov-20

Recall Number: D-1448-2019

Reason for Recall
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Initiated
05-06-2019
Reported
06-26-2019
Quantity
34521 100-count bottles

Recall Profile & Regulatory Data

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
Zydus Pharmaceuticals USA Inc
Nationwide in the USA
MethylPREDNISolone Tablets, USP, 4 mg, 100 tablets, Rx only, Manufactured by: Cadila Healthcare Ltd Ahmedabad, India NDC 68382-916-01

Batch or Lot Expiration Information

Lot# Lots: M800144, M800145, EXP, Feb-20; M808193, EXP Jun-20; M811096, EXPJul-20

Recall Number: D-1450-2019

Reason for Recall
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Initiated
05-06-2019
Reported
06-26-2019
Quantity
N/A

Recall Profile & Regulatory Data

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
Zydus Pharmaceuticals USA Inc
Nationwide in the USA
MethylPREDNISolone Tablets, USP 16 mg, 50 tablets, Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India NDC 68382-918-18

Batch or Lot Expiration Information

Lot# lots: M713034, M713035, M713036, EXP Nov-19; M814747 Sep-20; M819266, EXP Dec-20

Recall Number: D-1449-2019

Reason for Recall
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Initiated
05-06-2019
Reported
06-26-2019
Quantity
N/A

Recall Profile & Regulatory Data

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
Zydus Pharmaceuticals USA Inc
Nationwide in the USA
MethylPREDNISolone Tablets, USP 4 mg per tablet, 21 Tablets dosepack, Rx Only, Made in India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534. NDC 68382-916-34

Batch or Lot Expiration Information

Lot# Lots: M800150 Feb-20; M803930, M806006, M806007, M806008, M806009, M806010, M806011, EXP Mar-20; M807299, M807300, M807301, M807302, M807303, M807304, M807305, M807306, M807307, M807308, EXP May-20; M807779, M807780, M808194, M808195, M808196, M808197, M808198, EXP Jun-20; M811092, M811093, M811094, M811097, M811665, M811666, M811667, M813781, EXP Jul-20; M816286, M816288, M816289, M816290, M817612, EXP OCT-20; M817613, M817614, M817615, M817616, M818315, EXP Nov-20; M820619, M820620, M820621, M901594, M901595, M901596, M901597, M903484, EXP Mar-21