Drug recall: CycloSPORINE Capsules, USP, 100 mg, 30 count bottle, Rx Only, Manufactured by Apotex, Inc., Toronto, Ontario, Canada, Ma

FDA enforcement event 76402 · Class II · initiated 3 Feb 2017 · status Terminated · terminated 15 Jun 2022

DrugVoluntary: Firm initiated1 product recordNorth York, N/A

Apotex Inc. (North York, N/A) initiated this drug recall on 3 Feb 2017; FDA lists 1 product record under event 76402, classified Class II.

FDA defines Class II as 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. 57% of the 343 drug enforcement events initiated in 2017 carry the same class.

Status: Terminated, terminated 15 Jun 2022. Initiation: voluntary: firm initiated. Apotex Inc. has 20 enforcement events on this register, with a median of 1 product record per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

Apotex Inc., North York, N/A, Canada.

Reason for recall

"Failed Impurities/Degradations Specifications; out of specification results for Maximum Unknown Impurities and Total Impurities."

Distribution

"Distributed Nationwide"

Product records

Recall number	Product	Quantity	Class	Status	Report date
D-0475-2017	CycloSPORINE Capsules, USP, 100 mg, 30 count bottle, Rx Only, Manufactured by Apotex, Inc., Toronto, Ontario, Canada, Manufactured for Apotex Corp., Weston, FL --- NDC 60505-0134-0	19,584 bottles	Class II	Terminated	1 Mar 2017

Context

57%of 2017 drug events are Class II343 events that year

1product record in this eventfirm median: 1

20events on this register for the firm

Other enforcement events for Apotex Inc.

Initiated	Product (first record)	Type	Class	Records
27 May 2020	Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, 100 count bottles, Rx Only Manufactured by: Apotex, Inc. T	Drug	Class II	1
22 Oct 2019	Atorvastatin Calcium Tablets, USP 40 mg*, 1,000 count bottles, Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario Ca	Drug	Class III	1
24 Sep 2019	Walgreens Maximum Strength Wal-Zan 150 Ranitidine Tablets, USP 150 mg/Acid Reducer Distributed By: Walgreen Co., 200 Wil	Drug	Class II	6
1 Mar 2019	Drospirenone and Ethinyl Estradiol Tablets, USP, 3 mg/0.03 mg, 28 Tablets Blister, 1 Unit (NDC 60505-4183-1) packaged as	Drug	Class II	1
31 May 2018	Fluticasone propionate Nasal Spray, USP, 50 mcg, packaged in 50 mcg per spray 120 Metered Sprays bottles, 16 g net fill	Drug	Class II	1
8 May 2018	Piperacillin and Tazobactam for Injection, USP 3.375 gram/vial* 10-count Single Use Vials per carton, Rx Only, Mfg. by:	Drug	Class I	2
19 Dec 2016	Aripiprazole Tablets, 2 mg, 30-count bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada, M9L 1T9; M	Drug	Class III	1
25 Aug 2015	Bromfenac Ophthalmic Solution 0.09%, packaged in a) 1.7 mL bottle (NDC 60505-0595-05), b) 2.5 mL bottle (NDC 60505-0596-	Drug	Class II	1
17 Aug 2015	Cevimeline Hydrochloride Capsules, 30 mg a) 100 count bottle, and b) 500 count bottle, Rx Only, Manufactured by: Apotex	Drug	Class II	1
21 Jul 2015	Verapamil Hydrochloride Extended-Release tablets, USP, 240 mg, 500-count bottles, Rx Only, Apotex Corp. Manufactured by	Drug	Class III	1

All 20 events for Apotex Inc.

Questions and answers

Why was this drug recalled?

FDA's record gives the reason for recall as: "Failed Impurities/Degradations Specifications; out of specification results for Maximum Unknown Impurities and Total Impurities."

What does Class II mean?

FDA classifies recalls by relative degree of health hazard. 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.

Where was the product distributed?

FDA's distribution pattern field reads: "Distributed Nationwide"

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 15 Jun 2022. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.