Watson Laboratories recalls
Watson Laboratories appears in 22 official U.S. recall notices indexed by RecallRadar, most recently on 2014-02-05.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 22 |
|---|---|
| Published | 2012-07-11 to 2014-02-05 |
| By agency | FDA Drug (22) |
| By classification | Class II (12), Class III (9), Class I (1) |
| By status | terminated (22) |
| Distribution named in notices | AZ, CA, CT, FL, NV, OH, OK, PA, SC, US, WI |
Recalls
- Hydrocodone Bitartrate and Acetaminophen Tablets USP, CIII, 10 mg/ 660 mg, 100 count bottles, Rx only
FDA Drug · Class II · 2014-02-05 · Watson Laboratories
Reason: Failed Tablet/Capsule Specifications; Product contains broken tablets. - Carisoprodol Tablets, USP, CIV, 350 mg, 500 count bottle, Rx only
FDA Drug · Class II · 2014-01-15 · Watson Laboratories
Reason: Presence of Foreign Substance; metal particulates were visually observed in the tablets. - Next Choice" One Dose Emergency Contraceptive (Levonorgestrel Tablet), 1.5 mg, 1 Tablet/Blister Card (NDC 52544-287-54), Manufactured by Wa…
FDA Drug · Class II · 2013-10-16 · Watson Laboratories
Reason: Failed Tablet/Capsule Specifications: Multiple complaints for push through tablet breakage. - Oxycodone and Acetaminophen Tablets, USP 10 mg/650 mg, CII, 100 Count Bottles, Rx Only, Manufactured by: Watson Laboratories, Inc
FDA Drug · Class II · 2013-10-09 · Watson Laboratories
Reason: Presence of Foreign Tablets/Capsules: 20 tablets of Oxycodone/APAP 7.5/500 mg were found in a sealed 100 count bottle of Oxycodone and Acetaminophen Tablets, USP 10/650 mg lot# 705791A. - Hydrocodone Bitartrate and Acetaminophen Tablets, 7.5 mg/650 mg Tablets, 500 Count Bottle, Manufactured by: Watson Laboratories, Inc, Cocon…
FDA Drug · Class III · 2013-09-25 · Watson Laboratories
Reason: Defective Container: Defective bottles may not have tamper evident seals properly seated, and therefore it may be difficult to determine if the product had been opened or tampered with. - Oxycodone and Acetaminophen Capsules, USP 5mg/500 mg, packaged in a)100-count bottle (NDC 0591-0737-01), b) 500-count bottle (NDC 0591-0737…
FDA Drug · Class III · 2013-07-31 · Watson Laboratories
Reason: Subpotent drug: Two lots of Oxycodone and Acetaminophen Capsules, USP 5/500 mg are being recalled due to low out of specification (OOS) assay result obtained at expiry (24 months) for the oxycodone portion of the produc… - ZARAH¿ Drospirenone/ Ethinyl Estradiol Tablets, 3.0 mg/0.03 mg, Rx only, 3 tablet dispensers, 28 tablets each, Manuf. by: Watson Laboratori…
FDA Drug · Class II · 2013-03-27 · Watson Laboratories
Reason: Failed Tablet/Capsule Specification; tablet breakage while pushing through the blister pack (dispenser) . - Meprobamate
FDA Drug · Class II · 2013-03-27 · Watson Laboratories
Reason: Failed Impurities/Degradation Specifications: Watson Laboratories Inc. is recalling meprobamate because an out of specification result for an impurity diphenyl sulfone . - Meprobamate, Tablets USP, 200 mg, 100 tablets
FDA Drug · Class II · 2013-03-27 · Watson Laboratories
Reason: Failed Impurities/Degradation Specifications: Watson Laboratories Inc. is recalling meprobamate because an out of specification result for an impurity diphenyl sulfone . - Caziant (desogestrel and ethinyl estradiol) Tablets, USP, (Triphasic Regimen), 0.1 mg/0.025 mg, 0.125 mg/0.025 mg, 0.15 mg/0.025 mg, 28-cou…
FDA Drug · Class III · 2012-12-26 · Watson Laboratories
Reason: Impurities/Degradation Products: Out-of-specification results were obtained for a known impurities. - Hydrocodone Bitartrate and Acetaminophen Tablets USP, 10 mg/500 mg, 500-count Tablets per bottle, Rx only, Manufactured By: Watson Laborato…
FDA Drug · Class I · 2012-11-28 · Watson Laboratories
Reason: Superpotent (Multiple Ingredient) Drug: There is the potential for oversized and superpotent tablets. - Necon 10/11 (norethindrone and ethinyl estradiol) Tablets USP, 0.5 mg/35 mcg, 1 mg/35 mcg, inert tablets, 28-count tablets per dispenser pa…
FDA Drug · Class II · 2012-10-31 · Watson Laboratories
Reason: Cross Contamination With Other Products: The firm recalled Zovia, Lutera, Necon, and Zenchent, because certain lots could potentially be contaminated with trace amounts of Hydrochlorothiazide (HCTZ). - Lutera (levonorgestrel and ethinyl estradiol) Tablets USP, 0.1 mg/0.02 mg, inert tablets, 28-count tablets per dispenser packaged in 6 Tabl…
FDA Drug · Class II · 2012-10-31 · Watson Laboratories
Reason: Cross Contamination With Other Products: The firm recalled Zovia, Lutera, Necon, and Zenchent, because certain lots could potentially be contaminated with trace amounts of Hydrochlorothiazide (HCTZ). - Zenchent (norethindrone and ethinyl estradiol) Tablets USP, 0.4 mg/0.035 mg, 28-count tablets per dispenser packaged in 6 Tablet Dispensers…
FDA Drug · Class II · 2012-10-31 · Watson Laboratories
Reason: Cross Contamination With Other Products: The firm recalled Zovia, Lutera, Necon, and Zenchent, because certain lots could potentially be contaminated with trace amounts of Hydrochlorothiazide (HCTZ). - Zovia (ethynodiol diacetate and ethinyl estradiol) Tablets USP, 1 mg/35 mcg, inert tablets, 28-count tablets per dispenser packaged in 6 Ta…
FDA Drug · Class II · 2012-10-31 · Watson Laboratories
Reason: Cross Contamination With Other Products: The firm recalled Zovia, Lutera, Necon, and Zenchent, because certain lots could potentially be contaminated with trace amounts of Hydrochlorothiazide (HCTZ). - Necon 1/35-28 (norethindrone and ethinyl estradiol) Tablets USP, 1 mg/35 mcg, inert tablets, 28-count tablets per dispenser packaged in 6 T…
FDA Drug · Class II · 2012-10-31 · Watson Laboratories
Reason: Cross Contamination With Other Products: The firm recalled Zovia, Lutera, Necon, and Zenchent, because certain lots could potentially be contaminated with trace amounts of Hydrochlorothiazide (HCTZ). - Caziant (desogestrel and ethinyl estradiol) Tablets, USP, (Triphasic Regimen), 0.1 mg/0.025 mg, 0.125 mg/0.025 mg, 0.15 mg/0.025 mg, 28-cou…
FDA Drug · Class III · 2012-08-08 · Watson Laboratories
Reason: Impurities/Degradation Products: High Out-of-specification results were obtained for both known and unknown impurities. - Loxapine Capsules USP, 25mg, 100 count bottle, Rx only, Manufactured By: Watson Laboratories Inc., Corona, CA 92880 NDC # 0591-0371-01
FDA Drug · Class III · 2012-07-11 · Watson Laboratories
Reason: Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged. - Loxitane Capsules, Loxapine Succinate Capsules, 10mg base, 100 count bottle, Rx only, Watson Laboratories Inc., Corona, CA 92880 NDC # 5254…
FDA Drug · Class III · 2012-07-11 · Watson Laboratories
Reason: Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged. - Loxapine Capsules USP, 5mg, 100 count bottle, Rx only Manufactured By: Watson Laboratories Inc., Corona, CA 92880 NDC # 00591-0369-01
FDA Drug · Class III · 2012-07-11 · Watson Laboratories
Reason: Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged. - Loxapine Capsules USP, 10mg, 100 count bottle, Rx only, Manufactured By: Watson Laboratories Inc., Corona, CA 92880 Rx only
FDA Drug · Class III · 2012-07-11 · Watson Laboratories
Reason: Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged. - Loxapine Capsules USP, 50mg, 100 count bottle, Rx only Manufactured By: Watson Laboratories Inc., Corona, CA 92880 NDC # 0591-0372-01
FDA Drug · Class III · 2012-07-11 · Watson Laboratories
Reason: Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged.