Multi-event June 2022 FDA Recall Drug by Wedgewood Village Pharmacy, Llc
This Multi-event Class II drug recall was voluntarily initiated by Wedgewood Village Pharmacy, Llc on June 10, 2022 for the product Drug. The FDA reported the reason for recall as lack of processing controls. The product was distributed Nationwide and the recall is currently terminated.
Reported Recall Events
Recall Number: D-1184-2022
Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection
06-10-2022
07-13-2022
14 suppositories
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Wedgewood Village Pharmacy, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
N/A
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Products were distributed nationwide in the USA.
02-16-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Boric Acid 600 mg per suppository, 14 Vaginal Suppositories per box, Wedgewood Village Pharmacy LLC, 405 Heron Drive, Ste 200, Swedesboro, NJ 08085
Batch or Lot Expiration Information
Lot# : 000-03843532 Exp Date: 09/6/22
Recall Number: D-1185-2022
Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection
06-10-2022
07-13-2022
1 tube
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Wedgewood Village Pharmacy, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
N/A
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Products were distributed nationwide in the USA.
02-16-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Estriol 1mg/gm, Vaginal Cream, 30 gm tube, Qty: 1, Wedgewood Village Pharmacy LLC, 405 Heron Drive, Ste 200, Swedesboro, NJ 08085
Batch or Lot Expiration Information
Lot# : 000-03807142 Exp Date: 08/27/22
Recall Number: D-1181-2022
Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection
06-10-2022
07-13-2022
1 suspension bottle
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Wedgewood Village Pharmacy, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
N/A
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Products were distributed nationwide in the USA.
02-16-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Bethanechol Chloride 1mg/ml, 80 ml Suspension bottles Banana/Strawberry, Qty:1, Wedgewood Village Pharmacy LLC, 405 Heron Dr. Ste 200, Swedesboro, NJ 08085
Batch or Lot Expiration Information
Lot# : 000-03715131, Exp Date: 07/19/22
Recall Number: D-1186-2022
Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection
06-10-2022
07-13-2022
9/18/2022
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Wedgewood Village Pharmacy, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
N/A
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Products were distributed nationwide in the USA.
02-16-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Estriol 1mg/gm, Vaginal Cream, 60 gm tube, Qty: 1, Wedgewood Village Pharmacy LLC, 405 Heron Drive, Ste 200, Swedesboro, NJ 08085
Batch or Lot Expiration Information
Lot# : 000-03866709 Exp Date: 09/18/22
Recall Number: D-1183-2022
Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection
06-10-2022
07-13-2022
1 box
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Wedgewood Village Pharmacy, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
N/A
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Products were distributed nationwide in the USA.
02-16-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Boric Acid 600 mg capsules, 14 capsules per box, Qty: 1, Wedgewood Village Pharmacy LLC, 405 Heron Drive, Ste 200, Swedesboro, NJ 08085
Batch or Lot Expiration Information
Lot# : 000-03868160, Exp Date: 09/14/22
Recall Number: D-1182-2022
Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection
06-10-2022
07-13-2022
24 bottles
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Wedgewood Village Pharmacy, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
N/A
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Products were distributed nationwide in the USA.
02-16-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Doxycycline (as Calcium) (equivalent to 50mg/5mL), 10 mg/ml, 60 ml suspension bottles, Peppermint, Qty: 1, Wedgewood Village Pharmacy LLC, 405 Heron Dr, Ste 200, Swedesboro, NJ 08085
Batch or Lot Expiration Information
Lot# : 000-03852523, Exp Date: 09/01/22
Lot# : 000-03766625, Exp Date:07/10/22
Lot# : 000-03780127, Exp Date: 08/6/22
Lot# : 000-03794760, Exp Date: 08/6/22
Lot# : 000-03892723, Exp Date: 09/1/22
Lot# : 000-03641022, Exp Date: 06/17/22
Lot# : 000-03693714, Exp Date: 06/28/22
Lot# : 000-03770510, Exp Date: 08/6/22
Lot# : 000-03852462, Exp Date: 09/1/22
Lot# : 000-03840601, Exp Date: 09/1/22
Lot# : 000-03706934, Exp Date: 06/28/22
Lot# : 000-03850609, Exp Date: 09/1/22
Lot# : 000-03650269, Exp Date: 06/17/22
Lot# : 000-03870004, Exp Date: 09/1/22
Lot# : 000-03693748, Exp Date: 06/28/22
Lot# : 000-03904403, Exp Date: 09/1/22
Lot# : 000-03799564, Exp Date: 08/06/22
Lot# : 000-03723022, Exp Date: 06/28/22
Lot# : 000-03872892, Exp Date: 09/01/22
Lot# : 000-03885204, Exp Date: 09/01/22
Lot# : 000-03848586, Exp Date: 09/01/22
Lot# : 000-03903599, Exp Date: 09/01/22
Lot# : 000-03812001, Exp Date: 08/06/22
