Multi-event March 2014 FDA Recall Drug by Terra-medica Inc.

This Multi-event Class II drug recall was voluntarily initiated by Terra-medica Inc. on March 3, 2014 for the product Drug. The FDA reported the reason for recall as penicillin cross contamination. The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

D-1197-2014 TERMINATED D-1212-2014 TERMINATED D-1209-2014 TERMINATED D-1193-2014 TERMINATED D-1210-2014 TERMINATED D-1192-2014 TERMINATED D-1208-2014 TERMINATED D-1206-2014 TERMINATED D-1202-2014 TERMINATED D-1195-2014 TERMINATED D-1203-2014 TERMINATED D-1191-2014 TERMINATED D-1199-2014 TERMINATED D-1201-2014 TERMINATED D-1198-2014 TERMINATED D-1211-2014 TERMINATED D-1204-2014 TERMINATED D-1194-2014 TERMINATED D-1196-2014 TERMINATED D-1200-2014 TERMINATED D-1207-2014 TERMINATED D-1205-2014 TERMINATED

Recall Number: D-1197-2014

Reason for Recall
Penicillin Cross Contamination
Initiated
03-03-2014
Reported
04-16-2014
Quantity
55 10 x 1 mL Cartons; 51 50 x 1 mL Cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
67723
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Terra-Medica 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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Products were distributed US Nationwide, to Canada, to Philippines, and through internet sales.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-30-2014
Product Description About Product Description
Full technical description of the product.
Pleo Not PORTABLE SIPS, 6X, 10 x 1mL Cartons, Oral Homeopathic Medicine, OTC Only. Made in Germany, Distributed by: SANUM USA Corp.,1465 Slater Road, Fernadale, WA 98248; Manufactured By: SANUM-Kehlbeck GmbH & Co. KG. NDC: 49807-2308-1. Pleo Not PORTABLE SIPS, 6X, 50 x 1mL Cartons, Oral Homeopathic Medicine, OTC Only. Made in Germany, Distributed by: SANUM USA Corp.,1465 Slater Road, Fernadale, WA 98248; Manufactured By: SANUM-Kehlbeck GmbH & Co. KG. NDC: 49807-2308-2 .

Batch or Lot Expiration Information

Batch# (10 x 1mL)
Batch# 25050, EXP: April 2015. (50 x 1mL):
Batch# 25050, EXP: April 2015.

Recall Number: D-1212-2014

Reason for Recall
Penicillin Cross Contamination
Initiated
03-03-2014
Reported
04-16-2014
Quantity
428 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
67723
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Terra-Medica 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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Products were distributed US Nationwide, to Canada, to Philippines, and through internet sales.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-30-2014
Product Description About Product Description
Full technical description of the product.
Pleo Stolo DROPS 6X, 10ml Bottle; Homeopathic Anti-Inflammatory Medicine, OTC Only. Made in Germany for: SANUM USA Copr, 1456 Slater Road, Ferndale, WA 98248 by Sanum-Kehlbeck GmbH & Co. KG. NDC: 49807-0011-1.

Batch or Lot Expiration Information

Batch# 08060; EXP: May 2015
Batch# 07119, EXP: August 2014
Batch# 03043, EXP: May 2018.

Recall Number: D-1209-2014

Reason for Recall
Penicillin Cross Contamination
Initiated
03-03-2014
Reported
04-16-2014
Quantity
5940 Packages

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
67723
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Terra-Medica 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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Products were distributed US Nationwide, to Canada, to Philippines, and through internet sales.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-30-2014
Product Description About Product Description
Full technical description of the product.
Pleo Ex SUPPOSITORIES 3X, 10 Suppository Packages; Homeopathic Antifungal Medicine, OTC Only. Made in Germany. Distributed by: SANUM USA Corp., 1465 Slater Road, Ferndale, WA 98248. Manufactured by: Sanum-Kehlbeck GmbH & Co. KG. NDC: 49807-1001-1.

Batch or Lot Expiration Information

Batch# 2011; EXP: December 2015
Batch# 2081, EXP: July 2016
Batch# 3063, EXP: May 2018
Batch# 1013, EXP: February 2018.

Recall Number: D-1193-2014

Reason for Recall
Penicillin Cross Contamination
Initiated
03-03-2014
Reported
04-16-2014
Quantity
7408 cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
67723
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Terra-Medica 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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Products were distributed US Nationwide, to Canada, to Philippines, and through internet sales.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-30-2014
Product Description About Product Description
Full technical description of the product.
Pleo Not CAPSULES 4X, 20 Tablet Cartons, Oral Homeopathic Fever Reducer/ Cough Suppressant/ Decongestant Medicine, OTC Only. Made in Germany, Distributed by: SANUM USA Corp.,1465 Slater Road, Fernadale, WA 98248; Manufactured By: SANUM-Kehlbeck GmbH & Co. KG. NDC: 49807-2303-1.

Batch or Lot Expiration Information

Batch# 14010, EXP: December 2014
Batch# 11080, EXP: August 2015
Batch# 12092, EXP: July 2017.

Recall Number: D-1210-2014

Reason for Recall
Penicillin Cross Contamination
Initiated
03-03-2014
Reported
04-16-2014
Quantity
3440 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
67723
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Terra-Medica 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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Products were distributed US Nationwide, to Canada, to Philippines, and through internet sales.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-30-2014
Product Description About Product Description
Full technical description of the product.
Pleo Ex DROPS 5X, 10 ml bottles, Homeopathic Antifungal Medicine, OTC Only. Made in Germany for: SANUM USA Corp., 1465 Slater Road, Ferndale, WA 98248 by Sanum-Kehlbeck GMbH & Co. KG. NDC: 49807-1003-1.

Batch or Lot Expiration Information

Batch# 07011; EXP: December 2015
Batch# 09043, EXP: March 2108.

Recall Number: D-1192-2014

Reason for Recall
Penicillin Cross Contamination
Initiated
03-03-2014
Reported
04-16-2014
Quantity
4860 cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
67723
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Terra-Medica 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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Products were distributed US Nationwide, to Canada, to Philippines, and through internet sales.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-30-2014
Product Description About Product Description
Full technical description of the product.
Pleo Not SUPPOSITORIES 3X, 10 Suppository Cartons, Homeopathic Medicine, OTC Only. Made in Germany, Distributed by: SANUM USA Corp.,1465 Slater Road, Fernadale, WA 98248; Manufactured By: SANUM-Kehlbeck GmbH & Co. KG. NDC: 49807-2304-1.

Batch or Lot Expiration Information

Batch# 1080, EXP: July 2015
Batch# 1102, EXP: Septempber 2017.

Recall Number: D-1208-2014

Reason for Recall
Penicillin Cross Contamination
Initiated
03-03-2014
Reported
04-16-2014
Quantity
4770 Cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
67723
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Terra-Medica 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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Products were distributed US Nationwide, to Canada, to Philippines, and through internet sales.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-30-2014
Product Description About Product Description
Full technical description of the product.
Pleo Fort TABLETS 5X, 20 Tablet Carton, Homeopathic Digestive Aid Medicine, OTC Only. Made in Germany. Distributed by: SANUM USA Corp., 1465 Slater Road, Ferndale WA 98248. Manufactured by: Sanum-Kehlbeck GmbH & Co. KG. NDC: 49807-1102-1.

Batch or Lot Expiration Information

Batch# 27100; EXP: September 2015
Batch# 29100; EXP: October 2015
Batch# 25013; EXP: January 2018.

Recall Number: D-1206-2014

Reason for Recall
Penicillin Cross Contamination.
Initiated
03-03-2014
Reported
04-16-2014
Quantity
126 10 x 1 ml Cartons; 76 50 x 1ml Cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
67723
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Terra-Medica 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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Products were distributed US Nationwide, to Canada, to Philippines, and through internet sales.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-30-2014
Product Description About Product Description
Full technical description of the product.
Pleo Fort PORTABLE SIPS 5X, 10 x 1 mL Carton. Oral Homeopathic Medicine, OTC Only. Made in Germany for: SANUM USA Copr, 1456 Slater Road, Ferndale, WA 98248 by Sanum-Kehlbeck GmbH & Co. KG. NDC: 49807-1105-1. Pleo Fort PORTABLE SIPS 5X, 50 x 1 mL Carton. Oral Homeopathic Medicine, OTC Only. Made in Germany for: SANUM USA Copr, 1456 Slater Road, Ferndale, WA 98248 by Sanum-Kehlbeck GmbH & Co. KG. NDC: 49807-1105-2.

Batch or Lot Expiration Information

Batch# 10 x 1 ml Cartons:
Batch# 15030; EXP: February 2015
Batch# 12122; EXP: November 2017. 50 x 1 ml:
Batch# 15030; EXP: February 2015
Batch# 12122; EXP: November 2017.

Recall Number: D-1202-2014

Reason for Recall
Penicillin Cross Contamination
Initiated
03-03-2014
Reported
04-16-2014
Quantity
10,725 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
67723
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Terra-Medica 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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Products were distributed US Nationwide, to Canada, to Philippines, and through internet sales.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-30-2014
Product Description About Product Description
Full technical description of the product.
Pleo Quent DROPS 5X, 10 mL Bottles, Oral Homeopathic Medicine, OTC Only. Made in Germany for: SANUM USA Copr, 1456 Slater Road, Ferndale, WA 98248 by Sanum-Kehlbeck GmbH & Co. KG. NDC: 49807-2901-1.

Batch or Lot Expiration Information

Batch# 15129; EXP: November 2014
Batch# 12040, EXP: March 2015
Batch# 01081, EXP: August 2016.

Recall Number: D-1195-2014

Reason for Recall
Penicillin Cross Contamination
Initiated
03-03-2014
Reported
04-16-2014
Quantity
21,445 Bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
67723
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Terra-Medica 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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Products were distributed US Nationwide, to Canada, to Philippines, and through internet sales.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-30-2014
Product Description About Product Description
Full technical description of the product.
Pleo Not DROPS, 5X, 10 mL Bottles, Oral Homeopathic Medicine, OTC Only. Made in Germany, Distributed by: SANUM USA Corp.,1465 Slater Road, Fernadale, WA 98248; Manufactured By: SANUM-Kehlbeck GmbH & Co. KG. NDC: 49807-2301-1.

Batch or Lot Expiration Information

Batch# 21049, EXP: March 2014
Batch# 13059; EXP: April 2014
Batch# 09080, EXP: July 2015
Batch# 15100; EXP: September 2015
Batch# 24092; EXP: August 2017.

Recall Number: D-1203-2014

Reason for Recall
Penicillin Cross Contamination
Initiated
03-03-2014
Reported
04-16-2014
Quantity
211 10 x 1 ml vials; 152 50 x 1 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
67723
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Terra-Medica 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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Products were distributed US Nationwide, to Canada, to Philippines, and through internet sales.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-30-2014
Product Description About Product Description
Full technical description of the product.
Pleo Quent PORTABLE SIPS 5X, 10 x 1 ml Cartons, Oral Homeopathic Medicine, OTC Only. Made in Germany for: SANUM USA Copr, 1456 Slater Road, Ferndale, WA 98248 by Sanum-Kehlbeck GmbH & Co. KG. NDC: 49807-2905-1. Pleo Quent PORTABLE SIPS 5X, 50 x 1 ml Cartons, Oral Homeopathic Medicine, OTC Only. Made in Germany for: SANUM USA Copr, 1456 Slater Road, Ferndale, WA 98248 by Sanum-Kehlbeck GmbH & Co. KG. NDC: 49807-2905-2.

Batch or Lot Expiration Information

Batch# 10 x 1 ml:
Batch# 13090; EXP: August 2015. 50 x 1 ml:
Batch# 13090, EXP: August 2015.

Recall Number: D-1191-2014

Reason for Recall
Penicillin Cross Contamination
Initiated
03-03-2014
Reported
04-16-2014
Quantity
1368 tubes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
67723
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Terra-Medica 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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Products were distributed US Nationwide, to Canada, to Philippines, and through internet sales.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-30-2014
Product Description About Product Description
Full technical description of the product.
Pleo Not OINTMENT 3X, 30 g Tube, Topical Homeopathic Medicine, OTC Only. Made in Germany, Distributed by: SANUM USA Corp.,1465 Slater Road, Fernadale, WA 98248; Manufactured By: SANUM-Kehlbeck GmbH & Co. KG. NDC: 49807-2305-1.

Batch or Lot Expiration Information

Batch# 03051, EXP: April 2014
Batch# 13072, EXP: June 2015
Batch# 21033, EXP: April 2016.

Recall Number: D-1199-2014

Reason for Recall
Penicillin Cross Contamination
Initiated
03-03-2014
Reported
04-16-2014
Quantity
6120 cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
67723
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Terra-Medica 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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Products were distributed US Nationwide, to Canada, to Philippines, and through internet sales.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-30-2014
Product Description About Product Description
Full technical description of the product.
Pleo Nota- Quent DROPS 5X, 10 mL Bottles, Homeopathic Medicine, OTC Only. Made in Germany, Manufactured by: Sanum-Kehlbeck GmbH & Co. KG, Hoya, Germany. Distributed by: SANUM USA Corp., 1465 Slater Road, Ferndale, WA 98248. NDC: 49807-0031-1.

Batch or Lot Expiration Information

Batch# 04062 , EXP: May 2017
Batch# 06062 , EXP: May 2017.

Recall Number: D-1201-2014

Reason for Recall
Penicillin Cross Contamination
Initiated
03-03-2014
Reported
04-16-2014
Quantity
3066 cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
67723
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Terra-Medica 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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Products were distributed US Nationwide, to Canada, to Philippines, and through internet sales.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-30-2014
Product Description About Product Description
Full technical description of the product.
Pleo Quent CAPSULES 4X, 20 Capsule Cartons, Oral Homeopathic Medicine, OTC Only. Made in Germany for: SANUM USA Copr, 1456 Slater Road, Ferndale, WA 98248 by Sanum-Kehlbeck GmbH & Co. KG NDC: 49807-2902-1.

Batch or Lot Expiration Information

Batch# 25030; EXP: April 2015
Batch# 27101, EXP: Sept 2016.

Recall Number: D-1198-2014

Reason for Recall
Penicillin Cross Contamination
Initiated
03-03-2014
Reported
04-16-2014
Quantity
32 10 x 1 mL Cartons; 14 50 x 1 mL Cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
67723
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Terra-Medica 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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Products were distributed US Nationwide, to Canada, to Philippines, and through internet sales.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-30-2014
Product Description About Product Description
Full technical description of the product.
Pleo Not PORTABLE SIPS 7X,10 x 1 mL Cartons, Oral Homeopathic Medicine, OTC Only. Made in Germany, Distributed by: SANUM USA Corp., 1465 Slater Road, Ferndale, WA 98248. Manufactured by: Sanum-Kehlbeck GmbH & Co. KG. NDC: 49807-2310-1. Pleo Not PORTABLE SIPS 7X, 50 x 1 mL Cartons, Oral Homeopathic Medicine, OTC Only. Made in Germany, Distributed by: SANUM USA Corp., 1465 Slater Road, Ferndale, WA 98248. Manufactured by: Sanum-Kehlbeck GmbH & Co. KG. NDC: 49807-2310-2.

Batch or Lot Expiration Information

Batch# (10 x 1 mL) Portable Sips:
Batch# 20010, EXP: December 2014. (50 x 1ml) Portable Sips:
Batch# 20010, EXP: December 2014.

Recall Number: D-1211-2014

Reason for Recall
Penicillin Cross Contamination
Initiated
03-03-2014
Reported
04-16-2014
Quantity
111 10 x 1 mls; 39 50 x 1 mls

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
67723
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Terra-Medica 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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Products were distributed US Nationwide, to Canada, to Philippines, and through internet sales.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-30-2014
Product Description About Product Description
Full technical description of the product.
Pleo Ex PORTABLE SIPS 5X, 10 x 1 mL, Oral Homeopathic Medicine, OTC Only. Made in Germany. Distributed by: SANUM USA Corp. 1465 Slator Road, Ferndale, WA 98248. Manufactured by: Sanum-Kehlbeck GmbH & Co. KG, NDC: 49807-1005-1. PLEO--EX Portable Sips 5X, 50 x 1 mL, Oral Homeopathic Medicine, OTC Only. Made in Germany. Distributed by: SANUM USA Corp. 1465 Slator Road, Ferndale, WA 98248. Manufactured by: Sanum-Kehlbeck GmbH & Co. KG, NDC: 49807-1005-2.

Batch or Lot Expiration Information

Batch# 10 x 1 mL:
Batch# 09020; EXP: January 2015
Batch# 03052, EXP: April 2017. 50 x 1 mL:
Batch# 09020; EXP: January 2015
Batch# 03052, EXP: April 2017.

Recall Number: D-1204-2014

Reason for Recall
Penicillin Cross Contamination
Initiated
03-03-2014
Reported
04-16-2014
Quantity
2147 cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
67723
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Terra-Medica 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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Products were distributed US Nationwide, to Canada, to Philippines, and through internet sales.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-30-2014
Product Description About Product Description
Full technical description of the product.
Pleo Fort SUPPOSITORIES 3X, 10 Suppository Carton, Homeopathic Digestive Aid Medicine, OTC Only. Made in Germany for: SANUM USA Copr, 1456 Slater Road, Ferndale, WA 98248 by Sanum-Kehlbeck GmbH & Co. KG. NDC: 49807-1106-1.

Batch or Lot Expiration Information

Batch# 3110; EXP: October 2015
Batch# 1112; EXP: October 2017.

Recall Number: D-1194-2014

Reason for Recall
Penicillin Cross Contamination
Initiated
03-03-2014
Reported
04-16-2014
Quantity
4955 cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
67723
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Terra-Medica 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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Products were distributed US Nationwide, to Canada, to Philippines, and through internet sales.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-30-2014
Product Description About Product Description
Full technical description of the product.
Pleo Not TABLETS 5X, 20 Tablet Cartons, Oral Homeopathic Medicine, OTC Only. Made in Germany, Distributed by: SANUM USA Corp.,1465 Slater Road, Fernadale, WA 98248; Manufactured By: SANUM-Kehlbeck GmbH & Co. KG. NDC: 49807-2302-1.

Batch or Lot Expiration Information

Batch# 15070, EXP: June 2015
Batch# 24072, EXP: June 2017.

Recall Number: D-1196-2014

Reason for Recall
Penicillin Cross Contamination
Initiated
03-03-2014
Reported
04-16-2014
Quantity
730 10 x 1mL Cartons; 367 50 x 1 mL Cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
67723
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Terra-Medica 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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Products were distributed US Nationwide, to Canada, to Philippines, and through internet sales.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-30-2014
Product Description About Product Description
Full technical description of the product.
Pleo Not PORTABLE SIPS, 5X, 10 x 1mL Cartons, Oral Homeopathic Medicine, OTC Only. Made in Germany, Distributed by: SANUM USA Corp.,1465 Slater Road, Fernadale, WA 98248; Manufactured By: SANUM-Kehlbeck GmbH & Co. KG. NDC: 49807-2306-1. Pleo Not PORTABLE SIPS, 5X, 50 x 1mL Cartons, Oral Homeopathic Medicine, OTC Only. Made in Germany, Distributed by: SANUM USA Corp.,1465 Slater Road, Fernadale, WA 98248; Manufactured By: SANUM-Kehlbeck GmbH & Co. KG. NDC: 49807-2306-2.

Batch or Lot Expiration Information

Batch# (10 x 1mL):
Batch# 07099, EXP: August 2014
Batch# 15090; EXP: August 2015
Batch# 06120, EXP: November 2015
Batch# 19023; EXP: January 2018. (50 x 1ml) Portable Sips:
Batch# 07099, EXP: August 2014
Batch# 15090; EXP: August 2015
Batch# 1110, EXP: October 2015
Batch# 6120; EXP: November 2015
Batch# 19023; EXP January 2018.

Recall Number: D-1200-2014

Reason for Recall
Penicillin Cross Contamination
Initiated
03-03-2014
Reported
04-16-2014
Quantity
3725 cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
67723
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Terra-Medica 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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Products were distributed US Nationwide, to Canada, to Philippines, and through internet sales.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-30-2014
Product Description About Product Description
Full technical description of the product.
Pleo Quent SUPPOSITORIES 3X, 10 Suppository Cartons, Oral Homeopathic Medicine, OTC Only. Made in Germany for: SANUM USA Copr, 1456 Slater Road, Ferndale, WA 98248 by Sanum-Kehlbeck GmbH & Co. KG. NDC: 49807-2904-1.

Batch or Lot Expiration Information

Batch# 2089; EXP: June 2014
Batch# 3031 , EXP: June 2016.

Recall Number: D-1207-2014

Reason for Recall
Penicillin Cross Contamination
Initiated
03-03-2014
Reported
04-16-2014
Quantity
8405 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
67723
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Terra-Medica 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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Products were distributed US Nationwide, to Canada, to Philippines, and through internet sales.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-30-2014
Product Description About Product Description
Full technical description of the product.
Pleo-Fort DROPS 5X, 10ml bottle, Homeopathic Digestive Aid Medicine, OTC Only. Made in Germany for: SANUM USA Copr, 1456 Slater Road, Ferndale, WA 98248 by Sanum-Kehlbeck GmbH & Co. KG. NDC: 49807-1101-1.

Batch or Lot Expiration Information

Batch# 23109; EXP: September 2014
Batch# 08030; EXP: February 2015
Batch# 12032; EXP: February 2017
Batch# 26043; EXP: March 2018.

Recall Number: D-1205-2014

Reason for Recall
Penicillin Cross Contamination
Initiated
03-03-2014
Reported
04-16-2014
Quantity
4050 cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
67723
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Terra-Medica 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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Products were distributed US Nationwide, to Canada, to Philippines, and through internet sales.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-30-2014
Product Description About Product Description
Full technical description of the product.
Pleo Fort CAPSULES 4X, 20 Capsule Cartons Homeopathic Digestive Aid Medicine, OTC Only. Made in Germany for: SANUM USA Copr, 1456 Slater Road, Ferndale, WA 98248 by Sanum-Kehlbeck GmbH & Co. KG. NDC: 49807-1103-1.

Batch or Lot Expiration Information

Batch# 24030; EXP: February 2015
Batch# 14062; EXP: May 2017.