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Actavis Laboratories, FL, Inc.

1 ongoing recall and 6 historical records

Based on the official records currently available to Public Health Trace, 1 recall naming Actavis Laboratories, FL, Inc. is currently shown as ongoing. The other 6 records below are historical.

Public Health Trace has 7 recalls naming Actavis Laboratories, FL, Inc. as the recalling firm, republished from official FDA and USDA sources.

Recall records - 7 total

Recalls by year

A bar chart of the number of recalls naming this company by year.

Recalls by year
YearRecalls
20143
20153
20161
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FDA Recall OngoingHistorical recordClass III

Ramipril Capsules, USP, 1.25 mg, 30-count bottle, Rx only, Manufactured by: Arrow Pharm (Malta) Ltd., Birzebbugia, BBG3000, Malta; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, NDC 16252-570-30.

by Actavis Laboratories, FL, Inc.

Reason
Labeling: Incorrect or Missing Lot And/or Exp Date: Bottles labeled with the incorrect expiration date of 03/18 rather than 09/17.
Published
November 9, 2016
Distribution
Nationwide

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FDA Recall TerminatedTerminated: April 10, 2017Historical recordClass II

Metformin Hydrochloride Extended-Release Tablets, 1000 mg, 60-count bottle, Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314 USA; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 USA; NDC 0591-2720-60; UPC 3 05912 72060 3.

by Actavis Laboratories, FL, Inc.

Reason
Failed Dissolution Specifications: Low Out-of-Specification results for the 8 hour timepoint.
Published
October 21, 2015
Distribution
Nationwide

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FDA Recall TerminatedTerminated: December 30, 2016Historical recordClass III

Desmopressin Acetate Tablets, 0.1mg, 100 Count Bottles, Rx Only. Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314 USA; Distributed by Actavis Pharma, Inc. Parsippany, NJ 07054 USA. NDC: 0591-2464-01.

by Actavis Laboratories, FL, Inc.

Reason
Tablets/Capsules Imprinted with Wrong ID: Some tablets incorrectly imprinted with an X on one side.
Published
August 12, 2015
Distribution
Nationwide

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FDA Recall TerminatedTerminated: December 30, 2016Historical recordClass III

Cartia XT (diltiazem HCl extended-release capsules, USP), Once-A-Day Dosage, 300 mg, 90-count bottles, Rx only, Manufactured by: Watson Laboratories, Inc., Corona, CA --- NDC 62037-0600-90

by Actavis Laboratories, FL, Inc.

Reason
Presence of Foreign Substance; fine residue or dust identified as aluminum may be on exterior of the capsule shell
Published
April 22, 2015
Distribution
Nationwide

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FDA Recall TerminatedTerminated: June 16, 2015Historical recordClass II

Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75 mg/0.2 mg, 60-count bottle, Rx only. Manufactured by: Watson Laboratories, Inc., Corona, CA 92880, NDC: 0591-0398-60, UPC 3 05910 39860 6.

by Actavis Laboratories, FL, Inc.

Reason
Failed Tablet/Capsule Specifications: Presence of split or broken tablets.
Published
December 3, 2014
Distribution
Nationwide

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FDA Recall TerminatedTerminated: December 23, 2016Historical recordClass II

Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 50 mg/0.2 mg, 60-count bottle, Rx only, Manufactured by: Watson Laboratories, Inc., Corona, CA 92880, NDC 0591-0397-60, UPC 3 05910 39760 9.

by Actavis Laboratories, FL, Inc.

Reason
Failed Tablet/Capsule Specifications: Recall due to complaints of split or broken tablets.
Published
October 8, 2014
Distribution
Nationwide

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FDA Recall TerminatedTerminated: December 23, 2016Historical recordClass II

Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75 mg/0.2 mg, 60-count bottle, Rx only, Manufactured by: Watson Laboratories, Inc., Corona, CA 92880, NDC 0591-0398-60, UPC 3 05910 39860 6.

by Actavis Laboratories, FL, Inc.

Reason
Failed Tablet/Capsule Specifications: Recall due to complaints of split or broken tablets.
Published
October 8, 2014
Distribution
Nationwide

View recall →

Showing 1–7 of 7 results

Some FDA recall records on this page come from FDA's Enforcement Report database. Not every Enforcement Report record has a separate FDA.gov recall-announcement page.

This page lists recalls that name Actavis Laboratories, FL, Inc. as the recalling firm in the official source notice. It is not a safety rating, ranking, or statement that the company acted negligently. Read the full medical disclaimer.