Multi-event July 2015 FDA Recall Allergy Relief by Ohm Laboratories, Inc.

This Multi-event Class III drug recall was voluntarily initiated by Ohm Laboratories, Inc. on July 28, 2015 for the product Allergy Relief. The FDA reported the reason for recall as superpotent drug. The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

D-0032-2016 TERMINATED D-0039-2016 TERMINATED D-0027-2016 TERMINATED D-0026-2016 TERMINATED D-0036-2016 TERMINATED D-0034-2016 TERMINATED D-0030-2016 TERMINATED D-0028-2016 TERMINATED D-0024-2016 TERMINATED D-0038-2016 TERMINATED D-0022-2016 TERMINATED D-0021-2016 TERMINATED D-0029-2016 TERMINATED D-0019-2016 TERMINATED D-0020-2016 TERMINATED D-0033-2016 TERMINATED D-0035-2016 TERMINATED D-0025-2016 TERMINATED D-0037-2016 TERMINATED D-0031-2016 TERMINATED D-0023-2016 TERMINATED

Recall Number: D-0032-2016

Reason for Recall
Superpotent Drug: Out Of Specification (OOS) result for Assay.
Initiated
07-28-2015
Reported
10-21-2015
Quantity
311 boxes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71973
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Ohm Laboratories, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-28-2016
Product Description About Product Description
Full technical description of the product.
Ohm Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-count tablets, Distributed by Ohm Laboratories, Inc. 1385 Livingston Avenue, North Brunswick, NJ 08902, NDC 51660-527-31, UPC 3 5166052731 5

Batch or Lot Expiration Information

Batch# Batch Numbers: 2544486, Exp 7/31/2016; 2617891, Exp 5/31/2016; 2644272, Exp 9/30/2016

Affected Packages Involved in this Recall

51660-527-31 Allergy Relief

Recall Number: D-0039-2016

Reason for Recall
Superpotent Drug: Out Of Specification (OOS) result for Assay.
Initiated
07-28-2015
Reported
10-21-2015
Quantity
5,040 boxes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71973
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Ohm Laboratories, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-28-2016
Product Description About Product Description
Full technical description of the product.
Meijer Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-count tablets per box, Dist. By Meijer Distribution Inc. 2929 Walker Avenue NW, Grand Rapids, MI 49544. NDC 41250-527-31, UPC 7 6023662291 8

Batch or Lot Expiration Information

Batch# Batch Number: 2610783, Exp 4/30/2016

Recall Number: D-0027-2016

Reason for Recall
Superpotent Drug: Out Of Specification (OOS) result for Assay.
Initiated
07-28-2015
Reported
10-21-2015
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71973
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Ohm Laboratories, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-28-2016
Product Description About Product Description
Full technical description of the product.
Good Neighbor Pharmacy Loratadine Orally Disintegrating Tablets, USP, 10 mg, packaged in a) For kids 10-count tablets per box, NDC 24385-0161-52, ABC # 042-226, UPC 0 8770140650 8; b) For adults 10-count tablets, NDC 46122-0140-52, ABC# 059-535, UPC 0877014065546, Distributed by: AmerisourceBergen, 1300 Morris Drive, Chesterbrook, PA 19087

Batch or Lot Expiration Information

Batch# Batch Numbers: a) 2625092, Exp 6/30/2016; 2610783, Exp 4/30/2016 b) 2625093, Exp 6/30/2016, 2610783, Exp 4/30/2016

Recall Number: D-0026-2016

Reason for Recall
Superpotent Drug: Out Of Specification (OOS) result for Assay.
Initiated
07-28-2015
Reported
10-21-2015
Quantity
12,960 boxes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71973
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Ohm Laboratories, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-28-2016
Product Description About Product Description
Full technical description of the product.
Fred's Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-counts tablets per box, Distributed by: fred's, Inc., 4300 New Getwell Road, Memphis, TN 38118, UPC 0 8457912198 4.

Batch or Lot Expiration Information

Batch# Batch Numbers: 2544486, 2544487, Exp 7/31/2016; 2600127, Exp 2/29/2016; 2658140, Exp 11/30/2016

Recall Number: D-0036-2016

Reason for Recall
Superpotent Drug: Out Of Specification (OOS) result for Assay.
Initiated
07-28-2015
Reported
10-21-2015
Quantity
34,488 boxes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71973
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Ohm Laboratories, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-28-2016
Product Description About Product Description
Full technical description of the product.
Up&Up loratadine orally disintegrating tablets, USP, 10 mg, 30-count tablets per box, Distributed by Target Corp, Minneapolis, MN 55403; NDC 11673-527-31, UPC 3 5166052731 5

Batch or Lot Expiration Information

Batch# Batch Numbers: 2617892, 2617893, Exp 5/31/2016; 2625092, 2625093, Exp 6/30/2016; 2658137, 2658138, Exp 11/30/2016

Recall Number: D-0034-2016

Reason for Recall
Superpotent Drug: Out Of Specification (OOS) result for Assay.
Initiated
07-28-2015
Reported
10-21-2015
Quantity
33,984 boxes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71973
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Ohm Laboratories, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-28-2016
Product Description About Product Description
Full technical description of the product.
Safeway Care Loratadine Orally Disintegrating Tablets, USP, 10 mg, packaged in a) 10-count tablets per box (NDC 21130-527-69, UPC 3 2113076240 9); b) 30-count tablets per box (NDC 21130-527-31, UPC 3 2113076252 2) Distributed by Safeway Inc. PO BOX 99, Pleasanton, CA 94566

Batch or Lot Expiration Information

Batch# Batch Numbers: a) 2658140, Exp 11/30/2016; 2625092, Exp 6/30/2016; 2617893, Exp 5/31/2016; b) 2625092, Exp 6/30/2016; 2617893, Exp 5/31/2016; 2644265, Exp 9/30/2016

Recall Number: D-0030-2016

Reason for Recall
Superpotent Drug: Out Of Specification (OOS) result for Assay.
Initiated
07-28-2015
Reported
10-21-2015
Quantity
9,624 boxes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71973
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Ohm Laboratories, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-28-2016
Product Description About Product Description
Full technical description of the product.
Leader Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-count tablets per box, Distributed by Cardinal Health, Dublin, OH 43017, NDC 37205-745-65, UPC 0 9629512322 7

Batch or Lot Expiration Information

Batch# Batch Numbers: 2617891, Exp 5/31/2016; 2625092, Exp 6/30/2016

Recall Number: D-0028-2016

Reason for Recall
Superpotent Drug: Out Of Specification (OOS) result for Assay.
Initiated
07-28-2015
Reported
10-21-2015
Quantity
35,712 boxes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71973
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Ohm Laboratories, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-28-2016
Product Description About Product Description
Full technical description of the product.
Health Mart Pharmacy loratadine orally disintegrating tablets, USP, 10 mg, 10-count tablets per box, Distributed by: McKesson, One Post Street, San Francisco, CA 94104, NDC 62011-0073-1, UPC 0 5256913369 9

Batch or Lot Expiration Information

Batch# Batch Numbers: 2544488, Exp, 7/31/2016; 2617892, Exp 5/31/2016; 2625092, Exp 6/30/2016

Recall Number: D-0024-2016

Reason for Recall
Superpotent Drug: Out Of Specification (OOS) result for Assay.
Initiated
07-28-2015
Reported
10-21-2015
Quantity
4,176 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71973
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Ohm Laboratories, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-28-2016
Product Description About Product Description
Full technical description of the product.
Discount Drug Mart Food Fair, Original Prescription Strength, Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-count tablets per box, Distributed by: Drug Mart-Food Fair, Medina, OH 44256, UPC 0 93351 12101 2.

Batch or Lot Expiration Information

Batch# Batch Numbers: 2617892, Exp 5/31/2016

Recall Number: D-0038-2016

Reason for Recall
Superpotent Drug: Out Of Specification (OOS) result for Assay.
Initiated
07-28-2015
Reported
10-21-2015
Quantity
329,748 boxes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71973
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Ohm Laboratories, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-28-2016
Product Description About Product Description
Full technical description of the product.
Wal-itin Loratadine Orally Disintegrating Tablets, USP, 10 mg, packaged in a) 10-coiunt tablets per box, (NDC 0363-0527-69, ITEM 367492,UPC 3 1191717021 3); and b) 30-count tablets per box, (NDC 0363-0527-31, ITEM 254166, UPC 3 191715562 ) Distributed by Walgreen Co., 200 Wilmot Road, Deerfield, IL 60015

Batch or Lot Expiration Information

Batch# Batch Numbers: a) 2625093, Exp 6/30/2016; 2617893, Exp 5/31/2016; 2658137, 2658140, Exp 11/30/2016; 2644265, Exp 9/30/2016 b) 2544486, 2544487, 2544488, Exp 7/31/2016; 2600125, 2600126, 2600127, Exp 2/29/2016; 2644272, 2644273, 2644265, Exp 9/30/2016; 2625092, 2625093, Exp 6/30/2016; 2658137, 2658138, 2658140 Exp 11/30/2016; 2610783, Exp 4/30/2016; 2617891, Exp 5/31/2016.

Recall Number: D-0022-2016

Reason for Recall
Superpotent Drug: Out Of Specification (OOS) result for Assay.
Initiated
07-28-2015
Reported
10-21-2015
Quantity
21,356 boxes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71973
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Ohm Laboratories, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-28-2016
Product Description About Product Description
Full technical description of the product.
CareOne Original Prescription Strength, Allergy Relief, Loratadine Orally Disintegrating Tablets, USP, 10 mg, packaged in a) 10-count tablets per box, NDC 41520-525-69, UPC 3 41520 31346 2; b) Children's 10-count tablets per box NDC 41520-527-69, UPC 3 41520 31455 1; Distributed by: American Sales Company, 4201 Walden Avenue, Lancaster, NY 14086

Batch or Lot Expiration Information

Batch# Batch Numbers: (a) 2617891, Exp 5/31/2016; 2600127, Exp 2/29/2016; 2544487, Exp 7/31/2015; 2610783, Exp 4/30/2016 (b) 2600127, Exp 2/29/2016; 2544487, Exp 7/31/2015; 2617891, Exp 5/31/2016; 2644272, Exp 9/30/2016

Recall Number: D-0021-2016

Reason for Recall
Superpotent Drug: Out Of Specification (OOS) result for Assay.
Initiated
07-28-2015
Reported
10-21-2015
Quantity
18576 boxes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71973
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Ohm Laboratories, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-28-2016
Product Description About Product Description
Full technical description of the product.
Health Best Choice Care, Loratadine Orally Disintegrating Tablets, USP, 10 mg, 10-count tablets per box, Proudly Distributed by: Valu Merchandisers, Co., Kansas City, MO 64111; UPC 0 7003861209 4

Batch or Lot Expiration Information

Batch# Batch Numbers: 2625092, Exp 6/30/2016; 2644265, Exp 9/30/2016; 2600126, Exp 2/29/2016

Recall Number: D-0029-2016

Reason for Recall
Superpotent Drug: Out Of Specification (OOS) result for Assay.
Initiated
07-28-2015
Reported
10-21-2015
Quantity
25,488 boxes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71973
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Ohm Laboratories, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-28-2016
Product Description About Product Description
Full technical description of the product.
HEB Loratadine Orally Disintegrating Tablets, USP, 10 mg, 10-count tablets per box, Made with pride & care for HEB, San Antonio, TX 78204, Item code: 188330, UPC 0 4122081968 3

Batch or Lot Expiration Information

Batch# Batch Numbers: 2544486, Exp 7/31/2016; 2600127, Exp 2/29/2016; 2617891, Exp 5/31/2016; 2644265, Exp 9/30/2016

Recall Number: D-0019-2016

Reason for Recall
Superpotent Drug: Out Of Specification (OOS) result for Assay.
Initiated
07-28-2015
Reported
10-21-2015
Quantity
8,735 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71973
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Ohm Laboratories, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-28-2016
Product Description About Product Description
Full technical description of the product.
QC Quality Choice Loratadine Orally Disintegrating Tablets, USP 10 mg, 10-count tablets per box, Distributed by C.D.M.A., Inc., 43157 W. Nine Mile, Novi, MI 48376-0995, NDC 63868-157-10, UPC 6 35515 95777 0

Batch or Lot Expiration Information

Batch# Batch Numbers: 2644273, Exp 9/30/2016; 2600127, Exp 3/20/2016; 2544486, Exp 7/31/2016

Recall Number: D-0020-2016

Reason for Recall
Superpotent Drug: Out Of Specification (OOS) result for Assay.
Initiated
07-28-2015
Reported
10-21-2015
Quantity
90,410 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71973
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Ohm Laboratories, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-28-2016
Product Description About Product Description
Full technical description of the product.
Rite Aid Pharmacy loratadine orally disintegrating tablets USP, 10 mg, packaged in a) 30-count tablets per box, Item 352712, UPC 0 11822 52712 5; b) 60-count tablets per box, Item 353672, UPC 0 11822 53672 1. Distributed By: Rite Aid, 30 Hunter Lane, Camp Hill, PA 17011.

Batch or Lot Expiration Information

Batch# Batch Numbers: a) 2658137, Exp 11/30/2016; 2644272, Exp 9/30/2016; 2625093, 2625092 Exp 6/30/2016; 2617892, Exp 5/31/2016; 2610783, Exp 4/30/2016; 2600126, 2600128, Exp 2/29/2016 b) 2625093, Exp 6/30/2016; 2617892, Exp 5/31/2016; 2600128, Exp 2/29/2016

Recall Number: D-0033-2016

Reason for Recall
Superpotent Drug: Out Of Specification (OOS) result for Assay.
Initiated
07-28-2015
Reported
10-21-2015
Quantity
11,232 boxes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71973
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Ohm Laboratories, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-28-2016
Product Description About Product Description
Full technical description of the product.
Premier Value Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-count tablets per box; Distributed by Chain Drug Consortium, 3301 NW Boca Raton Blvd. Suite 101, Boca Raton, FL 33431, NDC 68016-527-31, UPC 8 4098601899 2

Batch or Lot Expiration Information

Batch# Batch Numbers: 2600126, Exp 2/29/2016; 2644273, Exp 9/30/2016

Recall Number: D-0035-2016

Reason for Recall
Superpotent Drug: Out Of Specification (OOS) result for Assay.
Initiated
07-28-2015
Reported
10-21-2015
Quantity
53,688 boxes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71973
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Ohm Laboratories, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-28-2016
Product Description About Product Description
Full technical description of the product.
TopCare LORATIDINE ORALLY DISINTEGRATING TABLETS, , USP, 10 mg, packaged in a) Children's 10-count tablets per box (NDC 36800-528-69, UPC 0 3680010261 3); and b) 10-count tablets per box, (NDC 36800-527-69, UPC 0 3680008395 0); Distributed by Topco Associates, LLC, Elk Grove Village, IL 60007.

Batch or Lot Expiration Information

Batch# Batch Numbers: a) 2600127, Exp 2/29/2016; 2617892, Exp 5/31/2016; 2644265, 9/30/2016; 2625092, Exp, 6/30/2016; 2658140, Exp 11/30/2016. b) 2617892, Exp 5/31/2016; 2610783, 4/30/2016; 2644272, Exp 9/30/2016

Recall Number: D-0025-2016

Reason for Recall
Superpotent Drug: Out Of Specification (OOS) result for Assay.
Initiated
07-28-2015
Reported
10-21-2015
Quantity
43,344 boxes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71973
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Ohm Laboratories, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-28-2016
Product Description About Product Description
Full technical description of the product.
Equaline Original Prescription Strength, loratadine orally disintegrating tablets, USP, 10 mg, packaged in a) 10-count tablets per box, NDC 41163-528-69, UPC 0 4116347138 2; and b) 30-count tablets per box, NDC 41163-528-31, UPC 0 4116346654 8; Distributed by: Supervalu Inc. Eden Prarie, MN 55344 USA

Batch or Lot Expiration Information

Batch# Batch Numbers: a) 2617892, Exp 5/31/2016; 2625092, Exp 6/30/2016; 2544486, 2544488, Exp 7/31/2016; 2600127, Exp 2/29/2016; 2644265, Exp 9/30/2016 b) 2544486, 2544488, Exp 7/31/2016; 2600127, Exp 2/29/2016; 2644265, Exp 9/30/2016

Recall Number: D-0037-2016

Reason for Recall
Superpotent Drug: Out Of Specification (OOS) result for Assay.
Initiated
07-28-2015
Reported
10-21-2015
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71973
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Ohm Laboratories, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-28-2016
Product Description About Product Description
Full technical description of the product.
Sunmark loratadine Orally Disintegrating Tablets, USP, 10 mg, packaged in a) 10-count tablets per box (NDC 49348-930-01, UPC 0 1093936544 6); and b) 30-count tablets per box (NDC 49348-930-44, UPC 0 1093934944 6) Distributed by McKesson, One Post Street, San Francisco, CA 94104

Batch or Lot Expiration Information

Batch# Batch Numbers: (a) 2544488, Exp 7/31/2016; 26917891, Exp 5/31/2016. (b) 2544488, Exp 7/31/2016; 2617893, Exp 5/31/2016; 2644273, Exp 9/30/2016

Recall Number: D-0031-2016

Reason for Recall
Superpotent Drug: Out Of Specification (OOS) result for Assay.
Initiated
07-28-2015
Reported
10-21-2015
Quantity
29,360 boxes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71973
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Ohm Laboratories, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-28-2016
Product Description About Product Description
Full technical description of the product.
Major loratadine orally disintegrating tablets, USP, 10 mg, 10-count tablets per box, Distributed by Major Pharmaceuticals 31778 Enterprise Drive, Livonia, MI 48150, USA, NDC 0904-5806-15, UPC 3 0904580615 9

Batch or Lot Expiration Information

Batch# Batch Numbers: 2644265, Exp 9/30/2016; 2658140, Exp 11/30/2016; 2625092, 2617891, Exp 5/31/2016; 2600127, Exp 2/29/2016; 2544488, 2544486, Exp 7/31/2016

Recall Number: D-0023-2016

Reason for Recall
Superpotent Drug: Out Of Specification (OOS) result for Assay.
Initiated
07-28-2015
Reported
10-21-2015
Quantity
291,312 boxes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71973
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Ohm Laboratories, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-28-2016
Product Description About Product Description
Full technical description of the product.
CVS Pharmacy, Original Prescription Strength, LORATADINE ORALLY DISINTEGRATING TABLETS, USP, 10 mg, packaged in a) 10-count tablets per box, Item 876239, UPC 0 50428 61152 4, and b) 30-count tablets per box, Item 367404, UPC 0 50428 11367 7, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895

Batch or Lot Expiration Information

Batch# Batch Numbers: a) 2644273, 2644265, Exp 9/30/2016; 2617891, 2617892, 2617893, Exp 5/31/2016; 2625093, 6/30/2016; 2544488, 7/31/2016; 2600125, 2600126, 2600127, Exp 2/29/2016; 2610783, Exp 4/30/2016 b) 2600128, Exp 2/29/2016; 2544487, Exp 7/31/2016; 2617893, Exp 5/31/2016; 2644265, Exp 9/30/2016; 2644272, Exp 9/30/2016; 2658138, Exp 11/30/2016