The Recall Desk
ModerateFDA (Drugs)·D-1182-2022·Announced 2022-07-13

Doxycycline oral suspension recalled for insanitary manufacturing conditions

Wedgewood Village Pharmacy LLC is recalling Doxycycline oral suspension (10 mg/ml, 60 ml bottles) nationwide due to insanitary conditions and lack of processing controls discovered during FDA inspection.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: FDA Class II recall with no reported illnesses or confirmed contamination. The hazard is precautionary based on manufacturing control deficiencies and insanitary conditions observed during inspection, fitting the criteria for a precautionary recall with no identified harm.

Plain-English summary

Wedgewood Village Pharmacy LLC is recalling multiple lots of Doxycycline (as Calcium) oral suspension (10 mg/ml, 60 ml bottles, peppermint flavor) distributed nationwide due to lack of processing controls and insanitary conditions discovered during a recent FDA inspection.

The FDA identified deficiencies in manufacturing controls that could result in potential microbial contamination of the product. The affected lots are: 000-03852523, 000-03766625, 000-03780127, 000-03794760, 000-03892723, 000-03641022, 000-03693714, 000-03770510, 000-03852462, 000-03840601, 000-03706934, 000-03850609, 000-03650269, 000-03870004, 000-03693748, 000-03904403, 000-03799564, 000-03723022, 000-03872892, 000-03885204, 000-03848586, 000-03903599, and 000-03812001. These lots have expiration dates ranging from June through September 2022.

Consumers and healthcare providers should stop using any affected lots and contact Wedgewood Village Pharmacy LLC at 405 Heron Dr, Suite 200, Swedesboro, NJ 08085 for instructions on return or disposal. Any patients who have used the affected product should consult their healthcare provider if they have concerns.

The recalled product

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
Manufacturer
Wedgewood Village Pharmacy, LLC
Category
Drug — Oral Suspension
Hazard
  • insanitary-conditions
  • processing-control-deficiency

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 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
  • 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
  • Lot#: 000-03852462
  • Lot#: 000-03840601
  • Lot#: 000-03706934
  • Lot#: 000-03850609
  • Lot#: 000-03650269
  • Lot#: 000-03870004

Distribution

Distributed nationwide across the United States.

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