The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-222-2013·Announced 2013-04-03

Physicians Total Care Tetracycline Recalled for Potential Foreign Particulate Matter

Physicians Total Care is recalling Tetracycline 500 mg capsules due to a potential for foreign particulate matter in the active pharmaceutical ingredient.

The agency’s classification

FDA (Drugs): Class II

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.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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: The recall is classified as FDA Class II, which typically corresponds to a Moderate severity score when no specific injuries or hospitalizations are reported in the source text.

Plain-English summary

Physicians Total Care, Inc. is recalling Tetracycline 500 mg capsules (30 capsules per bottle) manufactured by Teva Pharmaceuticals USA. The recall is due to a potential for foreign particulate matter in the active pharmaceutical ingredient (API).

The affected product is identified by NDC 54868-0025-09. Specific lot codes and expiration dates are listed in the recall notice, including lots expiring in 2012, 2013, and 2014. The product was distributed in Florida, North Carolina, Texas, Colorado, Virginia, South Carolina, Georgia, Kansas, Louisiana, and Missouri.

Consumers with this product should stop using it and contact their pharmacist or physician for guidance. The FDA has classified this recall as Class II, indicating that use of or exposure to the product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
PHYSICIANS TOTAL CARE, TETRACYCLINE, 500 mg, 30 CAPSULES, bottle MFG. BY: TEVA PHARMACEUTICALS USA, SELLERSVILLE PA 18960 NDC 54868-0025-09
Manufacturer
Physicians Total Care, Inc.
Category
Drug — Antibiotic
Hazard
Affected units
3,660

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 (13)

  • 5YLZ EXP 04/13
  • 5ZCE EXP 04/13
  • 61TX EXP 04/13
  • 65YD EXP 07/13
  • 6COJ EXP 09/13
  • 4ZT6 EXP 02/12
  • 58HD EXP 02/12
  • 5G4L EXP 08/12
  • 5KBU EXP 10/12
  • 5M3W EXP 10/12
  • 5OHI EXP 10/12
  • 6JHL EXP 01/14
  • 6HJQ EXP 01/14

Distribution

Distributed in 10 states:

Part of a larger recall action

This product is one of 2 recalled by Physicians Total Care, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same manufacturer · Physicians Total Care, Inc.

See all →

Same hazard · foreign particulate

See all →

Similar recalls